Compounds > prednisolone phosphate
Page last updated: 2024-12-06

prednisolone phosphate

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators

Description

Prednisolone phosphate is a synthetic corticosteroid, a type of steroid hormone. It is a prodrug, meaning it is converted to the active form, prednisolone, in the body. Prednisolone phosphate is used to treat a wide range of inflammatory and autoimmune conditions, including rheumatoid arthritis, lupus, and inflammatory bowel disease. It is also used to treat allergic reactions and certain types of cancer. Prednisolone phosphate works by suppressing the immune system and reducing inflammation. It is typically administered intravenously or intramuscularly. Research on prednisolone phosphate focuses on its efficacy, safety, and potential applications in various medical conditions. Studies are conducted to optimize its dosage and administration route, investigate its long-term effects, and explore new therapeutic uses. The importance of prednisolone phosphate lies in its ability to effectively control inflammation and immune system dysfunction in a wide range of diseases, improving patient outcomes and quality of life.'

prednisolone phosphate: RN given refers to (11 beta)-isomer [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

prednisolone phosphate : A synthetic glucocorticoid resulting from the formal condensation of the 21-hydroxy group of prednisolone with one of the hydroxy groups of phosphoric acid. It is a prodrug for prednisolone that is activated in vivo by phosphatases. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID72078
CHEMBL ID1201231
CHEBI ID145705
SCHEMBL ID136773
MeSH IDM0053389

Synonyms (24)

Synonym
einecs 206-120-1
prednisolone phosphate
11beta,17,21-trihydroxypregna-1,4-diene-3,20-dione 21-(dihydrogen phosphate)
prednisolone 21-(dihydrogen phosphate)
[2-[(8s,9s,10r,11s,13s,14s,17r)-11,17-dihydroxy-10,13-dimethyl-3-oxo-7,8,9,11,12,14,15,16-octahydro-6h-cyclopenta[a]phenanthren-17-yl]-2-oxoethyl] dihydrogen phosphate
prednisolone 21-phosphate
11beta,17-dihydroxy-3,20-dioxopregna-1,4-dien-21-yl dihydrogen phosphate
CHEBI:145705
prednisolone 21-monophosphate
302-25-0
unii-752sy38r6c
752sy38r6c ,
prednisolone phosphoric acid
CHEMBL1201231
predonine-21-phosphate
prednisolone phosphate [who-dd]
pregna-1,4-diene-3,20-dione, 11,17-dihydroxy-21-(phosphonooxy)-, (11.beta.)-
SCHEMBL136773
DTXSID7047481
DB14631
prednisolone-sodium-phosphate
Q27266327
EN300-7481415
{2-[(1r,3as,3bs,9ar,9bs,10s,11as)-1,10-dihydroxy-9a,11a-dimethyl-7-oxo-1h,2h,3h,3ah,3bh,4h,5h,7h,9ah,9bh,10h,11h,11ah-cyclopenta[a]phenanthren-1-yl]-2-oxoethoxy}phosphonic acid

Research Excerpts

Compound-Compound Interactions

ExcerptReferenceRelevance
" These results suggest that either salt of prednisolone, when combined with ciprofloxacin, reduces ocular inflammation without affecting the antimicrobial efficacy of the antibiotic."( Prednisolone acetate or prednisolone phosphate concurrently administered with ciprofloxacin for the therapy of experimental Pseudomonas aeruginosa keratitis.
Callegan, MC; Engel, LS; Hill, JM; Hobden, JA; O'Callaghan, RJ, 1993)		0.59

Bioavailability

ExcerptReferenceRelevance
"The superior bioavailability and therapeutic effect of prednisolone acetate over prednisolone sodium phosphate was described about 15 years ago."( The bioavailability and therapeutic effectiveness of prednisolone acetate vs. prednisolone sodium phosphate: a 20-year review.
Sousa, FJ, 1991)		0.28
"Comparative corneal penetration studies in the literature with prednisolone sodium phosphate solution and prednisolone acetate suspension administered to rabbit eyes give conflicting results concerning the greater bioavailability of prednisolone acetate."( Comparative corneal penetration of prednisolone sodium phosphate and prednisolone acetate in NZW rabbits.
Bidgood, AM; Musson, DG; Olejnik, O, 1991)		0.28
" The freely soluble succinate and phosphate esters were well absorbed in the jejunum."( Uptake of prodrugs by rat intestinal mucosal cells: mechanism and pharmaceutical implications.
Amidon, GL; Brabec, RK; Stewart, BH, 1986)		0.27
" In view of the low plasma prednisolone concentrations obtained, there are theoretical advantages in using a poorly absorbed enema to avoid the possibility of systemic steroid effects in patients requiring long term steroid treatment."( Therapeutic benefits from a poorly absorbed prednisolone enema in distal colitis.
Berghouse, L; English, J; Lennard-Jones, JE; Macrae, FA; McIntyre, PB, 1985)		0.27
" Human oral bioavailability is an important pharmacokinetic property, which is directly related to the amount of drug available in the systemic circulation to exert pharmacological and therapeutic effects."( Hologram QSAR model for the prediction of human oral bioavailability.
Andricopulo, AD; Moda, TL; Montanari, CA, 2007)		0.34
" Ocular irritation, bioavailability and anti-inflammatory effects were evaluated and compared with the conventional suspension and solution eye drops."( Preparation, characterization and evaluation of novel elastic nano-sized niosomes (ethoniosomes) for ocular delivery of prednisolone.
Abdallah, OY; Abdelkader, H; Farid, RM; Gaafar, PM, 2014)		0.4

Dosage Studied

ExcerptRelevanceReference
" The antitumor effects of the free drugs have only been observed using treatment schedules based on high and frequent dosing for prolonged periods of time."( Liposome-encapsulated prednisolone phosphate inhibits growth of established tumors in mice.
Fens, MH; Janssen, AP; Metselaar, JM; Molema, G; Schiffelers, RM; Storm, G, 2005)		0.64
" In a subsequent dose-response study, we found that a single dose of 1mg/kg liposomal prednisolone phosphate (PLP) was still equally effective in suppressing joint inflammation as 4 repeated once-daily injections of 10mg/kg free PLP."( Safety of glucocorticoids can be improved by lower yet still effective dosages of liposomal steroid formulations in murine antigen-induced arthritis: comparison of prednisolone with budesonide.
Hofkens, W; Nabbe, KC; Pesman, GJ; Storm, G; Sweep, FC; van den Berg, WB; van den Hoven, JM; van Lent, PL, 2011)		0.59
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (4)

RoleDescription
anti-inflammatory agentAny compound that has anti-inflammatory effects.
glucocorticoid receptor agonistAn agonist that selectively binds to and activates a glucocorticoid receptor.
prodrugA compound that, on administration, must undergo chemical conversion by metabolic processes before becoming the pharmacologically active drug for which it is a prodrug.
antineoplastic agentA substance that inhibits or prevents the proliferation of neoplasms.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (7)

ClassDescription
steroid phosphate
11beta-hydroxy steroidAny 11-hydroxy steroid in which the hydroxy group at position 11 has beta- configuration.
17alpha-hydroxy steroidThe alpha-stereoisomer of 17-hydroxy steroid.
20-oxo steroidAn oxo steroid carrying an oxo group at position 20.
3-oxo-Delta(1),Delta(4)-steroidA 3-oxo-Delta(1) steroid containing an additional double bond between positions 4 and 5.
tertiary alpha-hydroxy ketoneAn alpha-hydroxy ketone in which the carbonyl group and the hydroxy group are linked by a carbon bearing two organyl groups.
glucocorticoidGlucocorticoids are a class of steroid hormones that regulate a variety of physiological processes, in particular control of the concentration of glucose in blood.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Bioassays (3)

Assay IDTitleYearJournalArticle
AID91224Antiinflammatory activity measured by using McKenzie-Stoughton human vasoconstrictor assay1986Journal of medicinal chemistry, Nov, Volume: 29, Issue:11
Computer-aided studies of the structure-activity relationships between the structure of some steroids and their antiinflammatory activity.
AID311524Oral bioavailability in human2007Bioorganic & medicinal chemistry, Dec-15, Volume: 15, Issue:24
Hologram QSAR model for the prediction of human oral bioavailability.
AID90104Potency relative to fluocinolone 16,17-acetonide in the human vasoconstictor test1983Journal of medicinal chemistry, Mar, Volume: 26, Issue:3
Structure-activity relationships in the antiinflammatory steroids: a pattern-recognition approach.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (113)

TimeframeStudies, This Drug (%)All Drugs %
pre-199030 (26.55)18.7374
1990's19 (16.81)18.2507
2000's22 (19.47)29.6817
2010's39 (34.51)24.3611
2020's3 (2.65)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 70.46

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index70.46 (24.57)
Research Supply Index4.99 (2.92)
Research Growth Index4.65 (4.65)
Search Engine Demand Index121.45 (26.88)
Search Engine Supply Index2.02 (0.95)

This Compound (70.46)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials25 (20.66%)5.53%
Reviews3 (2.48%)6.00%
Case Studies12 (9.92%)4.05%
Observational0 (0.00%)0.25%
Other81 (66.94%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (701)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Electroretinographic Changes in Healthy Young Men Before and After Induction of Glucose Intolerance by Glucocorticoids Treatment, Hyperphagia and Lack of Exercise [NCT01140932]10 participants (Actual)Interventional2010-02-28Completed
EuroPainClinics® Study II (Prospective Randomized Double Blinded Trial) [NCT02459392]300 participants (Actual)Interventional2021-12-31Completed
Randomized, Masked Comparison of Bromfenac and Besifloxacin BID With Either Prednisolone BID or Loteprednol 0.5% BID for Prevention of Retinal Thickening and CME Following Phacoemulsification [NCT01193504]Phase 4100 participants (Anticipated)Interventional2010-09-30Recruiting
Efficacy and Tolerability of Systemic Methylprednisolone in Children and Adolescents With Chronic Rhinosinusitis [NCT01205984]Phase 448 participants (Actual)Interventional2007-07-31Completed
Vestibular Prognosis Assessment of the Idiopathic Sudden Sensorineural Hearing Loss With Vestibular Dysfunction Treated With Oral or Intratympanic Glucocorticoids [NCT03974867]72 participants (Anticipated)Interventional2019-07-31Not yet recruiting
Effect of Preoperative Administration of Dexamethasone Versus Methylprednisolone in Surgical Extraction of Retained Lower Third Molars [NCT05752305]Phase 2/Phase 384 participants (Actual)Interventional2022-01-15Completed
A Phase 1/2a Open-Label Ascending Dose Study to Evaluate the Safety and Effects of LY3884961 in Patients With Parkinson's Disease With at Least One GBA1 Mutation (PROPEL) [NCT04127578]Phase 1/Phase 220 participants (Anticipated)Interventional2020-01-03Recruiting
Anti-CD20 Antibody Rituximab in Addition to Prednisolone in Treatment of Warm Antibody Related Autoimmune Hemolytic Anemia. A Randomised Danish Multicenter Trial. [NCT01134432]Phase 365 participants (Actual)Interventional2005-03-31Completed
[NCT01137084]300 participants (Anticipated)Interventional2005-01-31Completed
Steroid Treatment as Anti-inflammatory and Neuroprotective Agent Following Out-of-Hospital Cardiac Arrest. A Randomized Trial [NCT04624776]Phase 2158 participants (Actual)Interventional2020-10-10Completed
An Investigator Initiated Open Study to Evaluate the Efficacy and Safety of Intra Arterial Infusion for Treatment of Steroid Resistant Acute Hepatic Graft Versus Host Disease (AGVHD) [NCT01140984]2 participants (Actual)Interventional2010-09-30Terminated(stopped due to technical issues)
Role of Add-on Azithromycin in the Management of Patients With Acute Exacerbation of Idiopathic Pulmonary Fibrosis [NCT05842681]30 participants (Anticipated)Interventional2023-06-01Not yet recruiting
Intravenous Methylprednisolone Versus High Dose Oral Prednisolone for the Treatment of Infantile Spasms: a Randomized Open-labelled Trial [NCT03876444]Phase 2/Phase 3128 participants (Anticipated)Interventional2019-04-01Recruiting
First-line Treatment of P53 Mutation With PD-L1 Expression in DLBCL With Anti-PD-1 Mab and R-CHOP: a Randomized, Open, Multicenter Clinical Study [NCT05280626]Phase 2100 participants (Anticipated)Interventional2022-03-25Not yet recruiting
Effect of Corticosteroids On MyocardiaL Injury Among Patients Hospitalized for Community-AcquirEd PneUMonia - COLOSSEUM TRIAL [NCT03745664]Phase 3122 participants (Anticipated)Interventional2021-01-10Recruiting
A Single-Center, Randomized, Double-Masked, Vehicle and Active-Controlled, Dose-Ranging Phase 2 Study Evaluating the Efficacy and Safety of PRT-2761 for the Treatment of Acute and Chronic Allergic Conjunctivitis Using the Conjunctival Allergen Challenge M [NCT03320434]Phase 2120 participants (Actual)Interventional2017-10-13Completed
Ruxolitinib and Methylprednisolone as First Line Therapy for Acute Graft Versus Host Disease Following Allogeneic Stem Cell Transplantation [NCT03701698]Phase 230 participants (Anticipated)Interventional2018-11-01Not yet recruiting
Efficacy and Safety of Subacromial Corticosteroid Injection in Type-2 Diabetic [NCT03652480]20 participants (Actual)Observational2013-03-31Completed
The Effect of a Preoperative Single-dose Methylprednisolone on the Postoperative Rehabilitation After Abdominal Hysterectomy: A Prospective, Double Blinded, Placebo Controlled Study [NCT01106547]Phase 455 participants (Anticipated)Interventional2009-08-31Completed
Sonographic Assessment in Severe Ulcerative Colitis Patients Admitted for Intravenous Corticosteroids and Eligible for Infliximab Rescue Therapy; a Prospective Clinician-blinded Observational Study Protocol. [NCT03942861]50 participants (Anticipated)Observational2019-02-21Recruiting
A Randomized Clinical Trial Comparing Hyaluronic Acid (Hylan G-F 20) and Corticosteroid (Methylprednisolone Acetate) for Knee Osteoarthritis [NCT01132677]78 participants (Anticipated)Interventional2010-05-31Enrolling by invitation
Preemptive Therapy Study of Cetuximab(Erbitux®)Induced Skin Rash Using Doxycycline, Sunscreen, Hydrocortisone and Moisturizer in Colorectal and Head and Neck Cancer Patients [NCT01874860]Phase 224 participants (Actual)Interventional2013-08-31Completed
Comparison Between Intra-articular Pulsed Radiofrequency With Steroids Injection Versus Intra-articular Steroids Injection in Chronic Sacroiliac Joint Arthritis [NCT03564106]Phase 2/Phase 340 participants (Actual)Interventional2019-03-01Completed
High-dose Busulfan, High-dose Cyclophosphamide, and Allogeneic Bone Marrow Transplantation for Leukemia, Myelodysplastic Syndromes, Multiple Myeloma and Lymphoma [NCT01177371]Phase 213 participants (Actual)Interventional1988-03-31Completed
Effect of Preoperative Intravenous High Dose Methylprednisolone on Orthostatic Intolerance and Heart Rate Variability in Patients Scheduled for Total Hip-arthroplasty [NCT02445898]Phase 2/Phase 364 participants (Actual)Interventional2015-09-30Completed
Randomized Clinical Trial Comparing Conventional Conservative Treatment for Plantar Fasciopathia With Endoscopic Surgery With Fascial Release. [NCT02448316]Phase 430 participants (Actual)Interventional2015-04-01Completed
Prospective Evaluation of Perioperative Steroid Dosing on Postsurgical Edema in Orthognathic Surgery [NCT03190642]Phase 4180 participants (Actual)Interventional2018-01-01Completed
Single Dose Oral Dexamethasone Versus Multi-dose Prednisolone in the Treatment of Acute Exacerbations of Asthma in Children Who Attend the Emergency Department [NCT03698630]Phase 4250 participants (Actual)Interventional2011-07-06Completed
Efficacy and Tolerance of Ultrasound-guided Needling and Lavage of Calcific Tendinitis of the Rotator Cuff Performed With or Without Subacromial Corticosteroid Injection: A Double Blind Controlled Study [NCT02403856]Phase 4136 participants (Actual)Interventional2015-04-04Completed
Cannabidiol for the Treatment of Severe (Grades III/IV) Acute Graft-versus-host Disease [NCT02392780]Phase 210 participants (Anticipated)Interventional2015-04-30Not yet recruiting
DEXTENZA Compared to Topical Steroid Therapy Prior to Cataract Surgery in Patients Who Receive Premium Intraocular Lenses [NCT04479748]Phase 413 participants (Actual)Interventional2020-10-01Completed
A Randomised Phase II Evaluation of Molecular Guided Therapy for Diffuse Large B-Cell Lymphoma With Acalabrutinib [NCT04546620]Phase 2453 participants (Anticipated)Interventional2021-10-19Recruiting
Can Injection of Methylprednisoloneacetate 80 mg, in the Cavity After Mastectomy for Primary Breast Cancer, at the Time of Removal of the Drain, Prevent Seroma Formation? [NCT01380912]160 participants (Anticipated)Observational2010-08-31Recruiting
Evaluating Clinical and Immunological Effects of Rituximab With Cyclophosphamide Compared to Rituximab Alone in AAV Patients [NCT03942887]Phase 3100 participants (Anticipated)Interventional2019-05-03Recruiting
To Study the Effect of Adjunctive Oral Methylprednisolone Therapy in Pediatric Urinary Tract Infection [NCT02331862]Phase 3160 participants (Anticipated)Interventional2015-01-31Not yet recruiting
A Single-center, Prospective, Non-comparative Clinical Trial of Ruxolitinib and Methylprednisolone as a First-line Treatment for Macrophage Activation Syndrome [NCT05137496]Phase 340 participants (Anticipated)Interventional2022-06-01Not yet recruiting
MP3-pulses-COVID-19. Methylprednisolone Pulses Versus Dexamethasone According RECOVERY Protocol in Patients With Pneumonia Due to SARS-COV-2 Coronavirus Infection [NCT04780581]Phase 4127 participants (Actual)Interventional2021-02-01Terminated(stopped due to Impossibility of reaching the sample size established by protocol)
An Open-Label, Single-Arm, Multiple Center Extension Study to Evaluate One Year of Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer With YONSA™ 500 mg (4 x 125 mg qd) With Methylprednisolone (4 mg Bid) [NCT02962284]Phase 220 participants (Actual)Interventional2016-11-30Completed
Corticosteroids for Acute Migraine. An ED-based, Randomized, Comparative Effectiveness Trial [NCT02847494]Phase 4220 participants (Actual)Interventional2016-09-01Completed
Health Related Quality of Life and Pain Managment Using Infiltration or Suprascapular Nerve Block Ultrasound Guided in Patients With Glenohumeral Arthirtis [NCT03794505]Phase 340 participants (Actual)Interventional2018-04-01Completed
Cyclic Oral Methylprednisolone Trial in Multiple Sclerosis [NCT01305837]Phase 230 participants (Actual)Interventional2011-04-30Completed
Clinical Study of Pirfenidone Combined With Methylprednisolone Versus Methylprednisolone in the Treatment of Checkpoint Inhibitor-related Pneumonitis [NCT05280873]Phase 148 participants (Anticipated)Interventional2021-10-10Recruiting
Efficacy and Cost-effectiveness of Intra-Articular Ketorolac Injection for Knee Osteoarthritis: A Randomized, Controlled, Double-Blinded Study [NCT03694821]Phase 418 participants (Actual)Interventional2018-07-05Terminated(stopped due to Low enrollment)
The Efficacy of Steroid Therapy in Vestibular Neuritis Confirmed by Head Impulse Test: Prospective Randomized Controlled Study [NCT02098330]Phase 340 participants (Actual)Interventional2014-03-31Completed
Evaluation of the Efficacy and Safety of Methylprednisolone Combined With the JAK Inhibitors in the Treatment of Toxic Epidermal Necrolysis: Two-arm, Open, Single-center Study [NCT06119490]Early Phase 130 participants (Anticipated)Interventional2023-07-05Recruiting
Corticosteroid(CS) Injections for the Treatment of Common Upper Extremity Pathologies, With or Without Lidocaine [NCT03704584]Phase 462 participants (Actual)Interventional2019-05-14Terminated(stopped due to Enrollment and study activities were initially suspended due to COVID-19. The investigator has also left Emory and the study will not resume.)
Phase II Study of Simvastatin, Zoledronic Acid, Bortezomib, Bendamustine and Methylprednisolone for Relapsed/Refractory Myeloma [NCT01332617]Phase 20 participants (Actual)Interventional2011-04-30Withdrawn(stopped due to Investigators no longer interested in activating study)
Feasibility and Safety of Umbilical Cord Blood Cell Transplant Into Injured Spinal Cord: an Open-Labeled, Dose-Escalating Clinical Trial [NCT01354483]Phase 1/Phase 220 participants (Actual)Interventional2011-09-30Completed
Combination Corticosteroids + 5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis. [NCT01941589]Phase 4149 participants (Actual)Interventional2013-09-30Completed
Subcutaneous Injection of TNFα Monoclonal Antibody for Treating Traumatic Acute Spinal Cord Injury [NCT04988425]Phase 1/Phase 290 participants (Anticipated)Interventional2022-09-01Not yet recruiting
A Comparative Study of Strategies for Management of Duchenne Myopathy in Assiut University Children Hospital [NCT03633565]Phase 445 participants (Anticipated)Interventional2018-09-30Not yet recruiting
Phase II Trial of Cisplatin Plus Etoposide Plus Gemcitabine Plus Solumedrol (PEGS) in Peripheral T-Cell Non-Hodgkin's Lymphoma [NCT00109928]Phase 234 participants (Actual)Interventional2005-09-30Completed
A Phase II, Open-labeled, Ophthalmological External Investigator-blinded, Single-center, Randomized, Superiority, Non Profit, Pilot Clinical Trial to Evaluate the Effects of Atorvastatin on Graves' Orbitopathy (GO) in Hypercholesterolemic Patients With Mo [NCT03110848]Phase 288 participants (Actual)Interventional2020-06-01Completed
Manipulation Versus Steroid Injection in the Treatment of Morton's Neuroma [NCT05707572]62 participants (Actual)Interventional2014-09-30Completed
Randomized, Double-blind, Placebo- and Active Comparator- Controlled Crossover Study in Healthy Male Subjects and an Open Label Study in Healthy Subjects and MS Patients to Assess the Safety, Pharmacokinetics and Pharmacodynamics of 2B3-201 [NCT02048358]Phase 147 participants (Actual)Interventional2013-11-30Terminated
Does Injection Site Matter? A Randomized Controlled Trial to Evaluate Efficacy of Knee Intraarticular Injections on Improval of Patient Reported Outcomes. [NCT02176304]Phase 460 participants (Actual)Interventional2014-06-30Completed
[NCT01281748]Phase 483 participants (Actual)Interventional2005-07-31Terminated(stopped due to Low rate of enrollment)
Safety and Efficacy of Oral Mega Pulse Methylprednisolone in Severe Therapy Resistant Alopecia Areata [NCT01167946]Phase 442 participants (Actual)Interventional2003-01-31Completed
Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas [NCT01189864]3,493 participants (Actual)Observational2010-02-01Terminated(stopped due to Terminated to initiate FDA IND-cleared study protocol)
Therapeutic Evaluation of Steroids in IgA Nephropathy Global Study Low Dose Study [NCT01560052]503 participants (Actual)Interventional2012-05-05Completed
Oral Megadose Corticosteroid Therapy of Acute Exacerbations of Multiple Sclerosis (OMEGA) [NCT00418145]Phase 316 participants (Actual)Interventional2003-09-30Terminated(stopped due to low enrollment - data was not analyzed for this study)
A Randomized, International, Multi Centre Study to Assess the Efficacy and Safety of Intravenous PEG-liposomal Prednisolone Sodium Phosphate (Nanocort®) vs Intravenous Methylprednisolone (Solu-Medrol®) Treatment in Patients With Acute Exacerbation of Rela [NCT01039103]Phase 215 participants (Actual)Interventional2009-12-31Terminated
Corticosteroid Treatment in the Acute Phase of Caustic Ingestion Management for the Prevention of Refractory Stenosis of the Esophagus and Pharynx- The CORTICAU Study [NCT03760354]Phase 230 participants (Anticipated)Interventional2019-02-15Not yet recruiting
Ultrasound-guided Medial Lumbar Bundle Branch Block by Caudal-cranial Approach: Radiographic Comparison of a New Ultrasound-guided Method [NCT05930236]40 participants (Anticipated)Interventional2023-04-21Recruiting
A Single-Cohort, Phase 2 Study of Ruxolitinib in Combination With Corticosteroids for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease (REACH-1) [NCT02953678]Phase 271 participants (Actual)Interventional2016-12-30Completed
Evaluation of clINical reCovery After a Relapse: a Pilot Study assEssing the Neuronal Effects of D-Aspartate in RR-MS Subjects Treated With IntErferon Beta 1a 44 mcg TIW (INCREASE) [NCT03387046]Phase 27 participants (Actual)Interventional2018-03-26Terminated(stopped due to Study was terminated early due to slow recruitment rate.)
A Prospective, Randomized, Controlled, Open Label, Assessor-blinded, Parallel-group Phase III Clinical Trial to Evaluate the Impact of Tapering Systemic Immunosuppressive Therapy in a Treat-to-target Approach on Maintaining Minimal Disease Activity in Adu [NCT04610476]Phase 3270 participants (Anticipated)Interventional2020-10-19Recruiting
Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion [NCT03327272]Phase 30 participants (Actual)Interventional2018-05-22Withdrawn(stopped due to Did not enroll, PI decided not to proceed.)
Single Arm Study To Assess Comprehensive Infusion Guidance For The Management Of The Infusion- Associated Reactions (IARs) In Relapsing-Remitting Multiple Sclerosis (RRMS) Patients Treated With LEMTRADA [NCT02205489]Phase 458 participants (Actual)Interventional2014-10-31Completed
A Trial of Prednisolone in Combination With SPI-62 or Placebo in Subjects With Polymyalgia Rheumatica (PMR) [NCT05436652]Phase 248 participants (Anticipated)Interventional2022-07-22Recruiting
Evaluation of Intraoperative Use of Dexycu on the Signs and Symptoms of Dry Eye [NCT04184999]Phase 440 participants (Actual)Interventional2019-08-10Completed
A Prospective, Randomized, Double-Blind Study to Compare the Effects of Dexamethasone Versus Depo-Medrol When Used in Lumbar Epidural Injections [NCT01397552]8 participants (Actual)Interventional2009-09-30Terminated(stopped due to Low enrollment, too many subjects getting second injection)
Phase II Study of Combination of Hyper-CVAD and Dasatinib (NSC-732517) With or Without Allogeneic Stem Cell Transplant in Patients With Philadelphia (Ph) Chromosome Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL) (A BMT Study) [NCT00792948]Phase 297 participants (Actual)Interventional2009-09-01Active, not recruiting
MRI Evaluation Assessing Synovitis to Address the Unmet Need for Reliable Endpoints in SLE [NCT03355482]Phase 240 participants (Anticipated)Interventional2017-04-10Suspended(stopped due to recruitment, funding)
Effects of Intraoperative Local Steroid Utilization in a Single-Level Minimally Invasive Transforaminal Lumbar Interbody Fusion [NCT03308084]Phase 3105 participants (Actual)Interventional2015-11-13Completed
A Phase 3/4, Prospective, Randomized, Active Treatment-Controlled, Parallel-Design, Multicenter Study to Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract [NCT05191706]Phase 460 participants (Anticipated)Interventional2022-01-04Recruiting
Glucocorticoid Inflammation Paradox in Human Skeletal Muscle [NCT03529929]Phase 30 participants (Actual)Interventional2019-06-01Withdrawn(stopped due to withdrawn)
The Effect of High Dose Steroid and Normobaric Oxygen Therapy on Recent Onset Non-arteritic Anterior Ischemic Optic Neuropathy(NAION); a Randomized Clinical Trial [NCT02439866]Phase 390 participants (Anticipated)Interventional2014-02-28Recruiting
A Randomized, Parallel Group, Double-masked, Active-controlled Phase 1/2 Clinical Trial to Evaluate the Efficacy and Safety of Dexamethasone Sodium Phosphate Visulex System for the Treatment of Non-infectious Anterior Uveitis [NCT02309385]Phase 1/Phase 244 participants (Actual)Interventional2014-10-31Completed
Targeting Steroid Resistance During Acute Exacerbations of Chronic Obstructive Pulmonary Disease With Respiratory Failure - The AECOPD Resistance Study [NCT03680495]46 participants (Anticipated)Observational [Patient Registry]2017-07-21Recruiting
Evaluation of Ultrasound Guided Platelet Rich Plasma Injection Versus Steroids Injection for Pain Relief in Cases of Partial Rotator Cuff Tears [NCT05317624]Early Phase 160 participants (Actual)Interventional2021-08-10Completed
Imatinib for Multiple Sclerosis (MS) Relapses - a Phase II, Randomised Study [NCT03674099]Phase 2200 participants (Anticipated)Interventional2018-10-01Recruiting
Calcific Tendinitis: Comparing Minimally Invasive Modalities [NCT02367560]60 participants (Anticipated)Interventional2015-07-31Recruiting
Effect of Preoperative Intravenous High Dose Methylprednisolone on Complement Activation in Patients Scheduled for Total Knee-arthroplasty [NCT02332616]Phase 370 participants (Actual)Interventional2015-01-31Completed
An Open-label, Phase 1/2 Study to Evaluate the Safety and Efficacy of Single-dose LY3884961 in Infants With Type 2 Gaucher Disease [NCT04411654]Phase 1/Phase 215 participants (Anticipated)Interventional2021-06-29Recruiting
Efficacy and Safety of Infliximab for Immune Checkpoint Inhibitor Induced Colitis: a Multinational, Randomised, Open Label, Phase III Trial - The iCaD Study [NCT05947669]Phase 3195 participants (Anticipated)Interventional2023-08-22Recruiting
[NCT02591953]22 participants (Actual)Interventional2015-11-30Terminated(stopped due to Unable to meet enrollment and follow up criteria)
Pulse Glucocorticoid Therapy in Patients With ST-Segment Elevation Myocardial Infarction [NCT05462730]Phase 2530 participants (Actual)Interventional2022-11-14Active, not recruiting
Oral Prednisolone for Acute Rhinovirus Induced Wheezing in Children Less Than 2 Years of Age: a Point-of-care Testing Guided Randomized, Double-blind, Placebo-controlled Trial [NCT05444699]Phase 4210 participants (Anticipated)Interventional2022-10-11Recruiting
Transforaminal Epidural Injection in Acute Sciatica [NCT03924791]142 participants (Anticipated)Interventional2019-06-01Recruiting
Phase II Study of Ofatumumab in Combination With High Dose Methylprednisolone Followed by Ofatumumab and Lenalidomide Consolidative Therapy for the Treatment of Untreated CLL/SLL The HiLOG Trial [NCT01496976]Phase 245 participants (Actual)Interventional2012-03-30Active, not recruiting
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of COLAL-PRED in the Treatment of Patients With Moderate to Severe Ulcerative Colitis [NCT00676832]Phase 2190 participants (Actual)Interventional2008-05-31Completed
Ultrasound Guided Continuous Suprascapular Nerve Block With Oral Gabapentin For Pain Management In Patients With Frozen Shoulder [NCT05037994]40 participants (Actual)Interventional2021-04-01Completed
A Phase 3, Multicenter, Randomized, Evaluator-blinded Clinical Trial to Assess the Safety and Efficacy of Clobetasol Propionate Ophthalmic Nanoemulsion, 0.05% Compared to Prednisolone Acetate, 1% in the Treatment of Inflammation After Cataract Surgery in [NCT05724446]Phase 360 participants (Anticipated)Interventional2022-12-12Recruiting
Chidamide Combines With Etoposide and Methylprednisolone in the Treatment of Hemophagocytic Lymphohistiocytosis [NCT05137522]20 participants (Anticipated)Interventional2021-07-01Recruiting
Local Steroid Injection vs Wrist Splinting for Carpal Tunnel Syndrome: A Randomized Clinical Trial [NCT02140632]Phase 450 participants (Actual)Interventional2013-12-31Completed
[NCT02253966]Phase 248 participants (Actual)Interventional2014-10-31Completed
Effect and Security of Steroids Therapy for Patients of IgA Nephropathy With Active Pathological Changes : A Prospective, Randomized, Controlled, Multi-Center Clinical Trial. [NCT02160132]Phase 2180 participants (Anticipated)Interventional2014-06-30Recruiting
Efficacy of Steroids on Functional Outcomes After Musculoskeletal Injuries of the Hand [NCT05003596]Phase 2/Phase 360 participants (Anticipated)Interventional2021-09-01Not yet recruiting
Effect of High-dose Glucocorticoids on Markers of Inflammation and Bone Metabolism in Patients With Primary Glomerular Disease [NCT04987450]40 participants (Anticipated)Observational2018-10-01Recruiting
A Parallel-arm, Single Blind Randomised Controlled Trial Comparing 'AIRWAY PRESSURE RELEASE VENTILATION' and 'LOW-TIDAL VOLUME VENTILATION' in Children With Acute Respiratory Distress Syndrome [NCT02167698]52 participants (Actual)Interventional2014-02-28Terminated(stopped due to Increased mortality in the intervention arm at 50% enrolment)
Stop LCNP: High Dose Steroid Therapy for Late Radiation-Associated Lower Cranial Neuropathy: A Phase I/II Dose Finding Trial and Data Registry [NCT04151082]Phase 1/Phase 215 participants (Actual)Interventional2019-10-31Active, not recruiting
Efficacy and Safety of Methylprednisolone Versus Dexamethasone in Caudal Block for Children Undergoing Hypospadias Surgical Repair: A Bi-center Randomized Controlled Study [NCT05717374]80 participants (Anticipated)Interventional2023-02-13Recruiting
The Efficacy and Safety of 36 Weeks Short-Term Optimization Treatment of Glucocorticosteroid in the Patients With Chronic Recurrent Drug-Induced Liver Injury [NCT03266146]Phase 1/Phase 290 participants (Actual)Interventional2017-09-02Completed
The Prospective Evaluation of Peri-Operative Glucocorticoid Use in the Management of Cervicofacial Infections of Odontogenic Origin [NCT05951504]Phase 2/Phase 329 participants (Actual)Interventional2022-06-22Completed
Corticosteroid Pulse Therapy Effects on MRI Asymptomatic Gadolinium-enhancing Lesions Conversion to a Non-enhancing Black Hole With or Without Treatment in MS Clinic of Booalisina Hospital Sari 2021-2023 [NCT04979650]Phase 2104 participants (Anticipated)Interventional2021-05-22Enrolling by invitation
The Impact of Dexamethasone Versus Methylprednisolone Upon Neutrophil/Lymphocyte Ratio (NLR) in COVID-19 Diseased Patients Admitted in ICU [NCT04909918]Phase 360 participants (Actual)Interventional2021-05-28Completed
Prevention of Development of Transcutaneous Sensitization in Children With Atopic Dermatitis During Their First Year of Life: an Observational Study [NCT04900948]Phase 4108 participants (Actual)Interventional2017-12-10Completed
Evaluation Of Vision Recovery And Comfort Index In Patients With Borderline/Mild Dry Eyes Undergoing Femtosecond Laser-Assisted Cataract Surgery With Premium Intraocular Lens - The ENHANCE Study [NCT04863742]Phase 430 participants (Anticipated)Interventional2021-04-26Recruiting
Single-blind, Investigator-initiated, Randomized, Controlled Trial to Assess the Safety and Efficacy of Intravenous Corticosteroid Therapy to Treat Patients With Acute Myocarditis With Mildly Reduced Left Ventricular Ejection Fraction [NCT05974462]Phase 3174 participants (Anticipated)Interventional2024-01-01Not yet recruiting
Evaluation of the Feasibility of Depomedrol Added to Bupivacaine in Ultrasound-guided Genicular Nerve Block in the Combination With Adductor Canal Block for Postoperative Analgesia and Rehabilitation After Reconstructive Knee Surgery. [NCT05893771]48 participants (Actual)Interventional2023-06-07Completed
Mechanisms of Neurodynamic Treatments (MONET) [NCT05859412]108 participants (Anticipated)Interventional2023-04-13Recruiting
Methylprednisolone Taper After Total Knee Replacement: A Prospective Randomized Trial [NCT05859269]Phase 4200 participants (Anticipated)Interventional2023-10-16Recruiting
Hypertonic Dextrose Versus Corticosteroid Intra-Articular Injections for the Treatment of Trapeziometacarpal Arthritis: A Prospective Double-blind Randomized Controlled Clinical Trial [NCT04791202]Phase 3130 participants (Anticipated)Interventional2021-04-01Not yet recruiting
Lateral Elbow Tendinopathy: A Randomized Controlled Trial Examining The Treatment Effect Of Strength Training Combined With Cortico-Steroid Injection, Dry-Needling Or Placebo [NCT02521298]60 participants (Actual)Interventional2015-10-31Completed
Procollagen-3 Driven Corticosteroids for Persistent Acute Respiratory Distress Syndrome [NCT03371498]Phase 3356 participants (Anticipated)Interventional2018-12-27Recruiting
High-dose Intravenous Methylprednisolone Therapy in Patients With Graves' Orbitopathy is Associated With the Increased Activity of Factor VIII [NCT03535090]26 participants (Actual)Observational2011-01-01Completed
Methylprednisolone Taper to Treat Delayed Post-Operative Recovery After Total Knee Arthroplasty: a Double-Blind Randomized Controlled Trial [NCT05113901]Phase 44 participants (Actual)Interventional2022-03-03Terminated(stopped due to Extremely low participation, decided to focus on similar study instead)
Benefit of a Flash Dose of Corticosteroids in Digestive Surgical Oncology: a Randomized, Double Blind, Placebo-controlled Trial [NCT03875690]Phase 31,200 participants (Anticipated)Interventional2019-07-02Recruiting
Comparative Study Between the Uses of High Dose Corticosteroid Therapy for Short Duration Versus Low Dose Corticosteroid for Long Duration in Severe Lung Contusion With ARDS [NCT04467892]Phase 2240 participants (Actual)Interventional2018-01-02Completed
International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL) Testing Imatinib in Combination With Two Different Cytotoxic Chemotherapy Backbones [NCT03007147]Phase 3475 participants (Anticipated)Interventional2017-08-08Recruiting
Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura [NCT03647852]150 participants (Anticipated)Interventional2019-09-01Recruiting
A Randomised Controlled Trial to Compare the Clinical Effectiveness of Lower Extremity Manipulation to That of Steroid Injection in the Treatment of Morton's Neuroma [NCT02304094]64 participants (Anticipated)Interventional2015-10-31Recruiting
GRAVITAS-301: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease [NCT03139604]Phase 3439 participants (Actual)Interventional2017-07-19Completed
The Efficacy of Nasal Steroids in Treatment of Otitis Media With Effusion: Acomparative Study [NCT03491098]Early Phase 160 participants (Anticipated)Interventional2018-05-15Not yet recruiting
Mycophenolate Mofetil and Prednisolone Versus Prednisolone Alone in Fibrotic Hypersensitivity Pneumonitis: a Randomized Controlled Trial [NCT05626387]Phase 4144 participants (Anticipated)Interventional2022-11-23Recruiting
A Prospective, Randomized, Controlled Phase Ⅱ Study of Preventively Use of Methylprednisolone After Split-course Chemoradiotherapy to Reduce the Risk of Radiation-induced Pulmonary Injury For Bulky Local Advanced None-small Cell Lung Cancer [NCT03661567]Phase 252 participants (Actual)Interventional2018-08-09Terminated(stopped due to slow enrollment)
A Double-masked, Methylprednisolone-control, Efficacy and Safety Study of 99Tc-MDP for Thyroid Associated Ophthalmopathy. [NCT03948191]Phase 450 participants (Actual)Interventional2017-10-16Completed
A Prospective, Open-label Trial of Methylprednisolone Pulse Macrolide Therapy for Refractory Mycoplasma Pneumoniae Pneumonia in Children [NCT01217099]47 participants (Actual)Interventional2007-05-31Terminated(stopped due to terminated)
Double-Masked, Randomized, Parallel Group Study for Evaluation of Non-Inferiority of 0.3%Gatifloxacin/1.0% Prednisolone Association Compared With Their Isolated Administration in the Prevention of Ocular Infection/Inflammation After LASIK Surgery [NCT01218737]Phase 3101 participants (Actual)Interventional2009-01-31Completed
The LIPMAT Study: Liposomal Prednisolone to Improve Hemodialysis Fistula Maturation [NCT02495662]Phase 230 participants (Actual)Interventional2015-11-30Terminated(stopped due to Slow inclusion)
Clinical Trial of Belimumab Combined With Multi-target Induction Therapy in Adult Patients With Severe Lupus Nephritis [NCT05863936]Phase 315 participants (Anticipated)Interventional2023-04-01Recruiting
Steroid Metabolism in Obese and Non-Obese Pediatric Patients Hospitalized for Status Asthmaticus [NCT04874610]15 participants (Actual)Observational2021-08-16Completed
A Phase II Study of Ofatumumab-High Dose Methylprednisolone Followed by Ofatumumab-Alemtuzumab in 17p Deletion CLL [NCT01465334]Phase 230 participants (Actual)Interventional2011-12-31Terminated(stopped due to Terminated early due to change in practice.)
The Effect of a New Antioxidant Combination (ASTED) on Moderate to Severe Thyroid Eye Disease, a Double Blind Placebo Controlled Randomized Clinical Trial [NCT02422368]Phase 2/Phase 30 participants (Actual)Interventional2022-09-01Withdrawn(stopped due to Do not access to the drug)
A Phase II Study Evaluating Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in Patients With Previously Untreated Double and Triple Hit Lymphoma, Double Expressor Lymphoma and High-Gr [NCT04479267]Phase 249 participants (Anticipated)Interventional2020-08-21Recruiting
An Open Label Study to Evaluate the Safety and Efficacy of Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Prior Treatment With Methotrexate [NCT01000610]Phase 418 participants (Actual)Interventional2008-03-17Completed
A Protocol Based Treatment for Early and Severe Systemic Sclerosis With (Anti-CD20), Rituximab [NCT00379431]Phase 29 participants (Actual)Interventional2006-11-27Completed
Phase 4, Randomized Study of Oral Glucocorticosteroid Administration in the Treatment of Acute Severe Asthma Exacerbation in Hospitalized Patients [NCT00627731]Phase 450 participants (Actual)Interventional2007-06-30Completed
Fludarabine, Mitoxantrone, and Dexamethasone (FND) Plus Chimeric Anti-CD20 Monoclonal Antibody (Rituximab) for Stage IV Indolent Lymphoma [NCT00577993]Phase 3210 participants (Actual)Interventional1998-03-16Completed
Impact of the Administration of Systemic Glucocorticoids on Inflammatory Response and Clinical Evolution of Patients Diagnosed With Moderate- Severe Bronchiolitis [NCT02571517]Phase 494 participants (Actual)Interventional2011-11-30Completed
Viral Inception of Asthma: Prospective Study From Infancy to School-age. [NCT00731575]200 participants (Anticipated)Interventional2007-06-30Active, not recruiting
Immunomodulatory Effect of Extracorporeal Cytokine Adsorption in Cardiac Surgery [NCT02666703]Phase 360 participants (Actual)Interventional2016-02-01Completed
Comparison of Intravenous Low Dose Versus High Dose Cyclophosphamide as Induction Therapy in the Treatment of Proliferative Lupus Nephritis [NCT02645565]Phase 475 participants (Actual)Interventional2015-12-31Completed
Propranolol vs Prednisolone for Infant Hemangiomas-A Clinical and Molecular Study [NCT00967226]Phase 219 participants (Actual)Interventional2009-07-31Terminated(stopped due to Serious adverse events with prednisolone, primarily temporary growth retardation, <5th percentile.)
Effectiveness of Hydrolyzed Collagen Peptide Injection for the Treatment of Collateral Ligament Pain: A Randomized Controlled Trial [NCT05971004]62 participants (Actual)Interventional2022-04-13Completed
Treatment With Methylprednisolone in Acute Exacerbations of Multiple Sclerosis: Enhanced Effect With Nighttime Treatment? [NCT00764413]57 participants (Actual)Interventional2009-04-30Terminated(stopped due to Low inclusion frequency and not enough human resources for completing study)
Subacromial Injection of Methylprednisolone Versus Ketorolac to Treat Shoulder Impingement: a Double-blind Randomized Controlled Trial [NCT03913702]Phase 21 participants (Actual)Interventional2019-09-09Terminated(stopped due to Inadequate patient enrollment)
Phase 2/3 Study of Rituximab for Graves' Ophthalmopathy [NCT00595335]Phase 2/Phase 325 participants (Actual)Interventional2008-04-30Completed
Intra-articular Doxycycline: A Novel Treatment of Adhesive Capsulitis [NCT03479502]Phase 41 participants (Actual)Interventional2018-01-05Terminated(stopped due to Lack of personnel to help with recruiting)
A Phase IV Trial of Neuroprotection With ACTH in Acute Optic Neuritis [NCT01838174]Phase 437 participants (Actual)Interventional2013-05-31Terminated(stopped due to Sponsor requested)
Efficacy and Safety of Prednisolone and Chloroquine Add on Therapy in Osteoarthritis of the Knee Treated With Fixed Dose Combination of Glucosamine and Chondroitin Sulfate. [NCT00805519]Phase 4230 participants (Actual)Interventional2009-02-28Completed
A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study To Evaluate The Safety And Efficacy Of TRU-015 In Subjects With Active Seropositive Rheumatoid Arthritis On A Stable Background Of Methotrexate [NCT00634933]Phase 2222 participants (Actual)Interventional2008-03-31Terminated(stopped due to The study was terminated on 21 June 2010 due to results not meeting the primary endpoint. No safety reasons contributed to the termination of the study.)
An Open-Label, Multicenter, Phase 1/2 Study of Tazemetostat as a Single Agent in Subjects With Advanced Solid Tumors or With B-cell Lymphomas and Tazemetostat in Combination With Prednisolone in Subjects With Diffuse Large B Cell Lymphoma [NCT01897571]Phase 1/Phase 2400 participants (Actual)Interventional2013-06-13Completed
Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of a BI 653048 BS H3PO4 Capsule Formulation Administered as Multiple Doses of 25 mg to 200 mg Once Daily (qd) for 3 Days Assessing Pharmacodynamics as Endotoxin-induced Inflammatory Response of a [NCT02224105]Phase 156 participants (Actual)Interventional2010-03-31Completed
A Multicenter, Randomized, Double-blind, Placebo-controlled TRial Evaluating Immunosuppressive Treatment in Patients With Chronic Virus-Negative Inflammatory cardiomyopaThY (TRINITY Trial) [NCT05570409]Phase 2/Phase 3130 participants (Anticipated)Interventional2023-03-28Recruiting
Assessment of the Efficacy of Medrol Dose Pack for Post-Concussive Headaches [NCT04685772]25 participants (Anticipated)Observational [Patient Registry]2021-04-01Recruiting
Methylprednisolone Pulse Therapy for Coronary Artery Dilatation or Aneurysm Formation in Kawasaki Disease [NCT04509219]Phase 110 participants (Anticipated)Interventional2020-04-15Recruiting
The Effect on Wrist Range of Motion With Perioperative Glucocorticoid Administration in the Treatment of Adult Distal Radius Fractures: A Randomized Controlled Trial [NCT03898154]Phase 4200 participants (Anticipated)Interventional2019-07-10Recruiting
The Outcome of Dexamethasone and Methylprednisolone Treatment for Patients With ARDS Caused by COVID-19 [NCT04499313]Phase 360 participants (Anticipated)Interventional2020-08-02Recruiting
A Feasibility Study to Undertake a Definitive Randomised Multi-centre, Double-blind, Double-dummy Controlled Study of a Novel Agent Anakinra vs. Depo-Medrone for Acute Gout Attacks in Patients With Moderate Chronic Kidney Disease [NCT02578394]Phase 2/Phase 321 participants (Actual)Interventional2016-04-30Completed
Effects of Methylprednisolone Plus Ropivacaine Infiltration Before Wound Closure on Laminoplasty or Laminectomy [NCT04493463]Phase 4132 participants (Actual)Interventional2020-07-31Completed
Syndrome du Tunnel Carpien - Essai Clinique randomisé évaluant l'efficacité de l'Utilisation de l'échographie Lors de l'Infiltration de corticostéroïdes [NCT02036125]50 participants (Anticipated)Interventional2013-10-31Recruiting
Zonisamide and Methylprednisolone to Prevent Noise-induced Temporary Hearing Loss [NCT02049073]Phase 1/Phase 20 participants (Actual)Interventional2017-10-31Withdrawn(stopped due to new data makes this trial unethical)
Randomised Trial of Intra-articular Injection of Lidocaine Versus Placebo in Inflammatory Arthritis [NCT05302232]80 participants (Anticipated)Interventional2022-04-18Not yet recruiting
Comparison of High-dose, Short-term Steroid and Low-dose Long-term Steroid Use in ARDS Caused by COVID-19 - Retrospective Cross-sectional Study [NCT05047874]200 participants (Anticipated)Observational2021-09-20Recruiting
An Open-Label, Parallel Group, Controlled Study in Healthy Subjects to Characterize Biological Responses to Immunological Challenges and to Measure the Effect of Marketed Anti-Inflammatory Agents on Those Responses [NCT02252809]Early Phase 151 participants (Actual)Interventional2008-11-30Completed
Comparative Evaluation of Preoperative Methylprednisolone or Ibuprofen on Anesthetic Efficacy of Inferior Alveolar Nerve Blocks in Patients With Symptomatic Irreversible Pulpitis [NCT04157036]Phase 33 participants (Actual)Interventional2020-02-01Terminated(stopped due to COVID halted recruitment for 2 years. A majority of patients eligible for the study had already taken preoperative analgesics, which disqualified them for the study.)
A Randomised Clinical Trial Assessing the Efficacy and Safety of Mycophenolate Mofetil Versus Azathioprine for Induction of Remission in Treatment Primary Biliary Cholangitis-Autoimmune Hepatitis Overlap Syndrome [NCT04933292]Phase 478 participants (Anticipated)Interventional2021-06-16Recruiting
Efficacy Assessment of Methylprednisolone and Heparin in Patients With COVID-19 Pneumonia: A Randomized, Controlled, 2x2 Factorial Study [NCT04485429]Phase 30 participants (Actual)Interventional2020-07-20Withdrawn(stopped due to It was not possible to perform the study due to the availability and logistics of porcine heparin)
Phase 2a, Double-blind, Randomized, Placebo-controlled Trial of Methylprednisolone Versus Placebo in Patients With Cognitive Deficits in Post-COVID-19 Syndrome (PCS) [NCT05986422]Phase 2418 participants (Anticipated)Interventional2023-10-01Recruiting
Effect and Security of Steroids Therapy for Patients of IgA Nephropathy With Crescents : A Prospective, Randomized, Controlled, Multi-Center Clinical Trial. [NCT04833374]Phase 3200 participants (Anticipated)Interventional2021-05-24Recruiting
Open-label Pilot Study of Methylprednisolone for the Treatment of Patients With Friedreich Ataxia (FRDA) [NCT02424435]Early Phase 111 participants (Actual)Interventional2015-06-30Completed
Comparison Of Efficacy Of Hydrocortisone And Methyl Prednisolone In Acute Severe Asthma [NCT06171932]60 participants (Anticipated)Observational [Patient Registry]2023-11-26Enrolling by invitation
A Pilot Study Examining Selinexor's Ability to Overcome Resistance in Multiple Myeloma Patients Who Are Refractory to Lenalidomide-containing Therapy. [NCT04519476]Phase 122 participants (Anticipated)Interventional2020-11-01Recruiting
Evaluation of the Efficacy of 2% Cyclosporine in Preventing Graft Rejection [NCT02206789]200 participants (Anticipated)Interventional2012-02-29Recruiting
Using SMART Design to Develop Dynamic Treatment Regimens for Glucocorticoid Tapering [NCT06072768]Phase 2200 participants (Anticipated)Interventional2023-03-09Recruiting
Impact of Cyclosporine or Steroid Withdrawal at 3 Months Post Transplantation on Graft Function, Patient Survival and Cardiovascular Surrogate Markers the First 5 Years After Renal Transplantation. [NCT00903188]Phase 4152 participants (Anticipated)Interventional2008-10-31Recruiting
Comparative Evaluation of the Efficacy and Tolerability of Prednisolone Acetate 0.5% Cream Versus Betamethasone Valerate 0.1% Cream in the Treatment of Pediatric and Adult Dermatosis [NCT01011621]Phase 3170 participants (Anticipated)Interventional2010-02-28Not yet recruiting
Randomised Double-blinded Trial Comparing Efficacy and Safety of Methylprednisolone Per os Versus IV for the Treatment of Multiple Sclerosis Relapses [NCT00984984]Phase 3200 participants (Anticipated)Interventional2008-03-31Recruiting
To Assess the Role of Sphingosine-1-phosphate in the Pathobiology of Pneumonia: Generate a New Strategy for Treatment of Severe Community-acquired Pneumonia [NCT04007328]Phase 2/Phase 3400 participants (Anticipated)Interventional2019-06-15Recruiting
(REASON) Double-blind, Randomized Phase II Study to Evaluate the Safety and Efficacy of Acetyl-l-carnitine in the Prevention of Sagopilone-induced Peripheral Neuropathy. [NCT00751205]Phase 2150 participants (Actual)Interventional2008-08-31Completed
Evaluation of a New Formulation Useful for the Osteoarthrosis Treatment [NCT00977444]Phase 2/Phase 3114 participants (Actual)Interventional2007-11-30Active, not recruiting
A Pilot Study To Determine The Toxicity Of The Addition Of Rituximab To The Induction And Consolidation Phases And The Addition Of Rasburicase To The Reduction Phase In Children With Newly Diagnosed Advanced B-Cell Leukemia/Lymphoma Treated With LMB/FAB T [NCT00057811]Phase 297 participants (Actual)Interventional2004-06-30Completed
Phase II Study of Cyclophosphamide, Prednisone and Rituximab (CPR) in Children, Adolescents and Young Adults With B-lymphocyte Antigen CD20 (CD20) Positive Post-Transplant Lymphoproliferative Disease (PTLD) Following Solid Organ Transplantation (SOT) [NCT00066469]Phase 255 participants (Actual)Interventional2004-04-30Completed
A Phase II Study of Panobinostat (LBH589) as Second-Line Therapy in Patients With Chronic Graft-Versus-Host Disease [NCT01028313]Phase 20 participants (Actual)InterventionalWithdrawn(stopped due to A decision was made to not move forward with the study. No participants were enrolled or treated.)
Assessment of Platelet Function in Patients With Chronic Autoimmune Thrombocytopenic Purpura (cAITP) Treated With the Thrombopoietin Receptor (MPL) Agonist Eltrombopag. [NCT00888901]Phase 430 participants (Actual)Interventional2009-05-31Completed
Prospective Donor-specific Cellular Alloresponse Assessment for Immunosuppression Minimization in de Novo Renal Transplantation [NCT02540395]184 participants (Actual)Interventional2015-03-31Completed
Impact of Obesity on the Pharmacokinetics of Anticancer Therapy in Children With High Risk Acute Lymphoblastic Leukemia (ALL) [NCT00900445]0 participants (Actual)Observational2008-03-24Withdrawn
Use of TNF-blocking Therapy in Combination With DMARDs in Patients With Early Rheumatoid Arthritis [NCT00908089]Phase 4100 participants (Actual)Interventional2003-03-31Active, not recruiting
Corticoids in Severe Community-acquired Pneumonia [NCT00908713]Phase 4120 participants (Actual)Interventional2004-01-31Completed
The Impact of Early Protocol Biopsy in Kidney Transplant Recipients Receiving TAC and MMF; a Prospective Observational Study [NCT02733510]200 participants (Anticipated)Observational2016-04-30Recruiting
ACP Max™ PRP System for Knee Osteoarthritis: A Feasibility Trial [NCT05765266]45 participants (Anticipated)Interventional2023-08-12Not yet recruiting
Clinical Treatment of Traumatic Optic Neuropathy: Optic Nerve Decompression Randomized Controlled Study [NCT02711982]2 participants (Anticipated)Interventional2010-01-31Recruiting
Greater Occipital Nerve Block for Migraine Prophylaxis [NCT00915473]Phase 470 participants (Actual)Interventional2009-06-30Completed
The Efficacy Of Magnesium In Radicular Lower Limb Pain When It Is Added To Local Anesthetics And Steroids In The Transforaminal Epidural Injections. A Comparative Study [NCT04532775]Phase 1100 participants (Anticipated)Interventional2020-08-30Not yet recruiting
A Pilot Randomized Controlled Trial of Efficacy of Perineural Local Anesthetics and Steroids for Chronic Post-traumatic Neuropathic Pain in the Ankle and the Foot: The PREPLAN Study [NCT02680548]Early Phase 18 participants (Actual)Interventional2015-11-30Completed
Ultrasound Guided Platelet Rich Plasma Injections for Post Traumatic Greater Occipital Neuralgia: A Randomized Controlled Pilot Study [NCT04051203]Phase 135 participants (Anticipated)Interventional2019-02-01Active, not recruiting
GRAVITAS-309: A Phase 2/3 Study of Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease [NCT03584516]Phase 2/Phase 3155 participants (Actual)Interventional2019-01-17Active, not recruiting
Glucocorticoid Therapy for Critically Ill Patients With Severe Acute Respiratory Infections Caused by COVID-19: a Prospective, Randomized Controlled Trial [NCT04244591]Phase 2/Phase 380 participants (Actual)Interventional2020-01-26Completed
Phenol Neurolysis of Genicular Nerves for Chronic Knee Pain Following Total Knee Arthroplasty: a Pilot Prospective, Randomized, Crossover Trial [NCT03973177]Phase 40 participants (Actual)Interventional2019-05-24Withdrawn(stopped due to Covid restrictions on recruitment)
A Prospective Study to Assess the Safety and Effectiveness of Medrol® in Acute Asthma in Indian Patients [NCT00971893]0 participants (Actual)Observational2009-10-31Withdrawn
A Phase Ib Feasibility Study of Personalized Kinase Inhibitor Therapy Combined With Induction in Acute Leukemias Who Exhibit In Vitro Kinase Inhibitor Sensitivity [NCT02779283]Phase 17 participants (Actual)Interventional2016-01-13Completed
A Phase 2, Randomized, Open-Label Study of Infliximab and Lower Exposure Corticosteroids vs Methylprednisolone and Higher Exposure Oral Corticosteroids for the Management of Immune-Related Severe or Persistent Diarrhea in Patients Treated With Yervoy (Ipi [NCT02763761]Phase 20 participants (Actual)Interventional2016-08-16Withdrawn(stopped due to Insufficient enrollment)
Sitagliptin Prophylaxis for Glucocorticoid-Induced Impairment of Glucose Metabolism and Beta-Cell Dysfunction in Males With the Metabolic Syndrome X: A Randomized, Placebo-controlled, Double-blind Intervention Study With a 2x2 Factorial Design [NCT00721552]82 participants (Actual)Interventional2008-10-31Completed
Effects of Volume and Dose of Local Anaesthetic Solution in Epidural Steroidal Injections for Patients With Chronic Lower Back Pain [NCT00887003]252 participants (Actual)Interventional2005-05-31Completed
A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy With Immuno-oncology Therapy for Children and Adults With Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma [NCT05675410]Phase 31,875 participants (Anticipated)Interventional2023-05-11Recruiting
A Phase 3 Trial Investigating Blinatumomab (NSC# 765986) in Combination With Chemotherapy in Patients With Newly Diagnosed Standard Risk or Down Syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients With Localized B-Lymphoblastic Lymphom [NCT03914625]Phase 36,720 participants (Anticipated)Interventional2019-07-03Recruiting
Transplantation of Umbilical Cord Blood for Myeloid Leukemia Patients Not in CR With Cyclophosphamide/Fludarabine/Total Body Irradiation Myeloablative Preparative Regimen and UCB NK Cells [NCT00354172]Phase 216 participants (Actual)Interventional2006-02-28Terminated(stopped due to Competing study was started.)
A Comparison of Three Different Formulations of Topical Prednisolone Acetate 1% for Control of Post Glaucoma and/or Cataract Surgery Inflammation. [NCT00345046]Phase 460 participants (Actual)Interventional2002-09-30Completed
Administration of Methylprednisolone for Prevention of Ovarian Hyper Stimulation Syndrome in In-vitro Fertilization Cycles: A Randomized Controlled Trial [NCT01014104]Phase 1/Phase 2218 participants (Actual)Interventional2009-10-31Completed
Trial of Early Aggressive Therapy in Juvenile Idiopathic Arthritis (TREAT in JIA) [NCT00443430]Phase 485 participants (Actual)Interventional2007-05-31Completed
Effects of Pre-operative Methylprednisolone (125mg iv) After Total Hip Arthroplasty: A Prospective, Randomized, Double-blind, Placebo-controlled Trail [NCT00968903]Phase 448 participants (Actual)Interventional2010-04-30Completed
Comparison of Monthly Pulse ACTH (Acthar Gel) Therapy With Methylprednisolone (MP, Solumedrol) for Long-Term Treatment of Multiple Sclerosis (MS) as an Add on Therapy to Beta-interferons (Avonex, Betaseron or Rebif) [NCT01049451]Phase 123 participants (Actual)Interventional2009-11-30Completed
Methylprednisolone Combined Electric-acupuncture Treatment Effects on Cognitive Function After Surgery for Elderly Patients With General Anesthesia [NCT02535039]Phase 1/Phase 280 participants (Anticipated)Interventional2015-10-31Recruiting
Autologous Followed by Non-myeloablative Allogeneic Transplantation for Non-Hodgkin's Lymphoma [NCT00481832]Phase 250 participants (Actual)Interventional2007-01-31Terminated(stopped due to Accrual Factor)
Comparison of the Efficacy and Safety of Tocilizumab Versus Methylprednisolone in the Cytokine Release Syndrome of Patients With COVID-19. A Prospective Randomized Controlled Phase II Trial [NCT04377503]Phase 230 participants (Actual)Interventional2020-05-01Terminated(stopped due to The number of critically ill patients wirh COVID-19 decrease abruptly)
Preoperative Methylprednisolone in Endovascular Aortic Repair - a Randomized Double Blind Placebo Controlled Clinical Trial [NCT00989729]150 participants (Actual)Interventional2009-10-31Completed
Phase 2 Clinical Trial for Comprehensive Treatment Program for Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN): Tagraxofusp (SL-401) in Combination With HCVAD/Mini-CVD and VENETOCLAX [NCT04216524]Phase 240 participants (Anticipated)Interventional2020-05-29Recruiting
Topical Epidural Steroid Usage in Patients Undergoing Posterior Lumbar Decompression: A Randomized Control Trial [NCT05058287]Phase 3150 participants (Anticipated)Interventional2021-11-05Recruiting
A Prospective, Randomized Single-Masked Clinical Trial Comparing OCT and Visual Acuity Outcomes in Subjects Undergoing Cataract Surgery, Who Receive Xibrom Ophthalmic Solution and Standard Presurgical Care vs. Xibrom Ophthalmic Solution Plus Prednisolone [NCT00698724]Phase 4200 participants (Anticipated)Interventional2008-06-30Completed
The MAGIC Algorithm Probability Guided Preemption of Steroid-refractory Graft-versus-host Disease With Methylprednisolone [NCT05368181]Phase 256 participants (Anticipated)Interventional2022-05-01Recruiting
Comparing Subacromial Injection of Platelet-rich Plasma Versus Methylprednisolone in the Treatment of Shoulder Subacromial Impingement Syndrome [NCT02669303]19 participants (Actual)Interventional2015-09-30Terminated(stopped due to low recruitment rate and high rate of loss-to-followup)
PreOperative Steroid in Abdominal Wall Reconstruction: A Double-blinded Randomized Clinical Trial [NCT02594241]42 participants (Actual)Interventional2016-03-31Completed
High-Dose Methotrexate Plus Steroid Followed by Concurrent Whole Brain Chemoradiation With Temozolomide for Immunocompetent Patients With Primary Central Nervous System Lymphoma - a Phase II Study [NCT00455286]Phase 225 participants Interventional2006-11-30Recruiting
Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt in Conjunction With Topical Drop Regimen Treating Pain and inflamMation Following Cataract Surgery Compared to SOC Topical Drop Regimen [NCT05626478]Phase 4100 participants (Anticipated)Interventional2023-06-01Recruiting
Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt in Conjunction With Topical Prednisolone Acetate 1% Treating Pain, and inflamMation Following Corneal Transplant Surgery Compared to Topical Prednisolone Acetate 1%. [NCT04521140]Phase 436 participants (Actual)Interventional2020-10-16Completed
Phase II Trial Of Yttrium-90-Ibritumomab Tiuxetan (Zevalin®) Radioimmunotherapy After Cytoreduction With ESHAP Chemotherapy In Patients With Relapsed Follicular Non-Hodgkin's Lymphoma [NCT00732498]Phase 228 participants (Actual)Interventional2006-05-15Completed
Low Dose Versus High Dose Steroids in Treatment of Viral Encephalitis [NCT04103684]Phase 4100 participants (Anticipated)Interventional2020-03-30Not yet recruiting
Effectiveness of Transtympanic Steroids in Unilateral Ménière's Disease: a Randomised Controlled Double-Blind Trial [NCT00802529]Phase 2/Phase 360 participants (Actual)Interventional2009-04-30Completed
"Are Steroids Efficacious in Hospitalized Patients With Bronchiolitis Who Show an Objective Clinical Improvement After Albuterol (Albuterol Responders)?" [NCT00798616]0 participants (Actual)InterventionalWithdrawn(stopped due to We were unable to enroll a sufficient number of patients due to manpower.)
Assessment of Clinical Efficacy of 1% Prednisolone Acetate (Ster ®), Produced by união química, Compared to 1% Prednisolone Acetate (Pred ® Fort), Produced by Allergan, in the Control of Postoperative Inflammation in Cataract Surgery. [NCT01227876]Phase 3106 participants (Actual)Interventional2011-01-31Completed
Prospective Comparison of Sirolimus Against Corticosteroids in Treatment of Patients With Active Thyroid Eye Disease [NCT04936854]Phase 260 participants (Anticipated)Interventional2023-01-01Recruiting
Corticosteroids and Azathioprine Versus Corticosteroids Alone in IgA Nephropathy: a Randomized Controlled Trial. [NCT00755859]Phase 4206 participants (Actual)Interventional1998-05-31Completed
Determination of Optimum Duration of Treatment With Bromfenac (Xibrom) Eyedrops Following Cataract Surgery [NCT00758199]Phase 449 participants (Actual)Interventional2008-07-31Completed
An Observational, Retrospective, Single-center, Clinical Study to Evaluate the Efficacy of Sirolimus (Rapamycin) in Patients With Graves' Disease and Moderate-to-severe and Active Graves' Orbitopathy (GO) [NCT05345119]30 participants (Actual)Observational2020-01-15Completed
Phase I/II Study of Hyper-CVAD Plus RAD001 (Everolimus) for Patients With Relapsed or Refractory Acute Lymphocytic Leukemia (ALL) [NCT00968253]Phase 1/Phase 224 participants (Actual)Interventional2009-11-30Completed
An Open-label Extension (OLE), Expanded Access Study, to Assess Long-term Safety of SoluMatrix™ Abiraterone Acetate 500mg (4 x 125 mg qd) With Methylprednisolone (4mg Bid) in Patients Who Completed Study Number CHL-AA-201 [NCT02887976]Phase 32 participants (Actual)Interventional2016-09-30Completed
The Effect of Steroid Pulse Therapy for the Reduction of Acute Rejection Episode in Subclinical Borderline Changes: An Open-Label, Randomized Clinical Trial [NCT02664493]154 participants (Anticipated)Interventional2016-02-29Recruiting
Treatment of Chronic Subdural Hematoma by Corticosteroids [NCT02650609]Phase 3202 participants (Actual)Interventional2016-06-24Completed
Anabolic and Inflammatory Responses to Short-Term Testosterone Administration in Older Men [NCT00957801]Phase 429 participants (Actual)Interventional2009-03-31Completed
A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle Following Cataract Surgery in Diabetic Retinopathy Patients [NCT00782717]Phase 2263 participants (Actual)Interventional2008-11-30Completed
Local Steroid Injection in the Treatment of Idiopathic Carpal Tunnel Syndrome: A Randomized Double-blind Placebo-controlled Trial Among Patients Planned for Surgical Treatment [NCT00806871]Phase 2/Phase 3112 participants (Actual)Interventional2008-11-30Completed
Hematopoietic Stem Cell Therapy for Patients With Refractory Myasthenia Gravis [NCT00424489]Phase 19 participants (Actual)Interventional2002-02-28Terminated(stopped due to No participants enrolled for more than two years. No plan to continue study.)
Phase 4, Randomized Study of Three Months-prednisolone Therapy in the Treatment of Chronic Eosinophilic Pneumonia [NCT00632554]Phase 450 participants (Anticipated)Interventional2008-06-30Completed
Effect of Anti-inflammatory Topical Prednisolone Acetate 1%, Nepafenac of 0.1% and Ketorolac Tromethamine 0.4% in Intra-operative Mydriasis in Facetectomies [NCT00865540]Phase 430 participants (Actual)Interventional2009-03-31Active, not recruiting
Intra-discal Steroid Injection for MODIC I Discopathy: A Randomized Control Trial [NCT00804531]Phase 4137 participants (Actual)Interventional2009-04-30Completed
Role of Doxycycline in the Management of Patients With Chronic Rhinosinusitis With Nasal Polyps [NCT05157412]Phase 360 participants (Anticipated)Interventional2022-03-01Not yet recruiting
Randomized, Prospective Single-center Study Comparing a Rapid Discontinuation of Corticosteroids (Steroid Withdrawal) With Corticosteroid Therapy in Kidney Transplantation Using Mycophenolate Mofetil and Tacrolimus Maintenance Therapy [NCT00596947]Phase 418 participants (Actual)Interventional2005-10-31Terminated(stopped due to due to low study enrollment)
Evaluation of Efficacy in the Resolution of Post-Operative Inflammation and Pain in Patients Receiving Omidria and Dexycu, or Omidria and Dextenza Compared to Topical Prednisolone Acetate 1% Following Cataract Surgery [NCT04316936]Phase 415 participants (Actual)Interventional2019-12-10Completed
GON-injection for a Sooner and Better Treatment of Cluster Headache: a Double-blind Randomized Controlled Trial [NCT04014634]Phase 480 participants (Anticipated)Interventional2019-08-01Recruiting
A Phase I, Randomised, Single-blind Study to Asses the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of AZD9567 in Healthy Volunteers Using Prednisolone as Positive Control [NCT02760316]Phase 164 participants (Anticipated)Interventional2016-05-02Completed
Rituximab Plus Short-term Methylprednisolone Versus Standard Dose Methylprednisolone in Newly Diagnosed Participants With Immune Thrombocytopenia (ITP): A Multicenter, Randomized Phase II Study in China [NCT02757196]Phase 2112 participants (Anticipated)Interventional2016-05-31Not yet recruiting
Budesonide Inhalation Suspension for Acute Asthma in Children [NCT00393367]Phase 4179 participants (Actual)Interventional2006-12-31Completed
An Open Label, Multicenter, Phase I/II Study of IBI377 in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease [NCT04220632]Phase 1/Phase 21 participants (Actual)Interventional2020-06-18Terminated(stopped due to Adverse events of the first patient)
A Phase IIIB, Multicenter, Randomized, Double-Masked, Parallel-Group, Active-Controlled Study of the Safety and Efficacy of Difluprednate Ophthalmic Emulsion, 0.05% (Durezol™) 4 Times Daily (QID) and Prednisolone Acetate Ophthalmic Suspension, 1.0% (Pred [NCT01124045]Phase 380 participants (Actual)Interventional2010-08-31Completed
Intrathecal Rituximab in Progressive Multiple Sclerosis [NCT02545959]Phase 210 participants (Actual)Interventional2015-11-30Completed
Multicenter, Randomized, Double Blind, Clinical Trial to Compare the Clinical and Radiological Efficacy of Equivalent Doses of Methylprednisolone Administered Orally or Intravenously in Patients With Multiple Sclerosis During Relapse [NCT00753792]Phase 449 participants (Actual)Interventional2008-11-30Completed
Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II：A Randomized Controlled Open-label Clinical Trial [NCT04617561]Phase 490 participants (Anticipated)Interventional2020-11-01Recruiting
Steroid Injection for the Treatment of Greater Trochanteric Pain Syndrome: A Randomized Controlled Trial [NCT00863889]Phase 40 participants (Actual)Interventional2009-03-31Withdrawn
An Unusual Association Between Pancreatic Cancer and Purtscher-like Retinopathy: Presentation of a Unique Case [NCT05350384]1 participants (Actual)Observational2021-06-18Completed
Steroids and Azathioprine in Early and Advanced IgA Nephropathy: Amendments to a Prospective Randomised Multicenter Trial [NCT01392833]Phase 346 participants (Actual)Interventional1999-12-31Completed
Phase I Study of Escalating Doses of Carfilzomib With Hyper-CVAD in Patients With Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma [NCT02293109]Phase 110 participants (Actual)Interventional2015-12-17Completed
Phase 1, Open-label, Randomized, Single-dose, 2-treatment, Crossover Be Study Comparing Constituted Methylprednisolone Powder For Oral Suspension 4 Mg/ml To Methylprednisolone 16 Mg Tablet Under Fasting Conditions [NCT01405157]Phase 10 participants (Actual)Interventional2012-01-01Withdrawn
A Phase IV Single Blind Placebo-controlled Cross Over Study to Investigate the Efficacy of Greater Occipital Nerve Block With Local Anesthetic and Steroid in Patients With Chronic Migraine [NCT04017741]Phase 48 participants (Actual)Interventional2018-02-14Completed
Randomised Trial of Plasma Exchange or High Dose Methyl Prednisolone as Adjunctive Therapy for Severe Renal Vasculitis [NCT01408836]Phase 2/Phase 3150 participants (Actual)Interventional1995-03-31Terminated(stopped due to Completed)
Comparison Between Standard Dose Methyl Prednisolone and Megadose Methyl Prednisolone as Regards Outcome in SARS.COV.2 Patients in Intensive Care Unit : Retrospective Study [NCT05279482]104 participants (Actual)Observational2022-01-19Completed
A Randomized Phase II Study for the Evaluation of Extracorporeal Photopheresis (ECP) in Combination With Corticosteroids for the Initial Treatment of Acute Graft-Versus-Host Disease (GVHD) [NCT00609609]Phase 281 participants (Actual)Interventional2008-01-31Completed
Effects of Pre-operative Methylprednisolone (125mg iv) After Total Knee Arthroplasty: A Prospective, Randomized, Double-blind, Placebo-controlled Trail [NCT00968578]Phase 448 participants (Actual)Interventional2009-08-31Completed
Phase II Study of The Modified Hyper-CVAD Program for Acute Lymphoblastic Leukemia [NCT00671658]Phase 2220 participants (Actual)Interventional2002-11-30Completed
Effect of Preoperative Intravenous High Dose Methylprednisolone on Immune Signaling in Patients Scheduled for Total Hip-arthroplasty [NCT02542592]Phase 2/Phase 364 participants (Actual)Interventional2015-09-30Completed
Umbilical Cord Blood (UCB) Allogeneic Stem Cell Transplant for Hematologic Malignancies [NCT01093586]Phase 214 participants (Actual)Interventional2007-09-30Completed
A Randomized Pilot Trial of a Steroid-free Immunosuppressant Regimen in Pediatric Liver Transplantation [NCT00694408]Phase 315 participants (Actual)Interventional2008-06-30Terminated(stopped due to Study terminated due to withdrawal from market of Daclizumab)
An Open, Prospective/Retrospective, Randomized Controlled Cohort Study to Compare the Efficacy of Different Hormone Doses in the Treatment of 2019-nCoV Severe Pneumonia [NCT04263402]Phase 4100 participants (Anticipated)Interventional2020-02-01Recruiting
Prednisolone-induced Impairment of Glucose Metabolism and Beta-cell Dysfunction and the Protective Effects of Exenatide: a Single-center, Randomized, Double-blind, Placebo-controlled Crossover Study in Healthy Volunteers [NCT00744224]8 participants (Anticipated)Interventional2009-02-28Completed
Phase III Randomised Study on Liposomal Cytarabine (DepoCyte®) vs. Intrathecal Triple for CNS-Treatment During Maintenance Therapy in High-Risk Acute Lymphoblastic Leukemia Patients in NOPHO ALL 2008 Treatment Protocol [NCT00991744]Phase 3100 participants (Anticipated)Interventional2009-01-31Suspended(stopped due to Sterility problems in DepoCyte production)
Efficacy of Vigabatrin With High Dose Prednisolone Combination Therapy Versus Vigabatrin Alone for Infantile Spasm: a Randomized Trial [NCT04302116]250 participants (Anticipated)Interventional2020-05-18Recruiting
Pilot Randomized, Placebo-Controlled Trial to Evaluate The Effect of Oral Pulsed Methylprednisolone on Seizure Frequency in Pediatric Patients With Idiopathic Intractable Convulsive Epilepsy [NCT04219995]Phase 1/Phase 210 participants (Anticipated)Interventional2020-02-03Recruiting
Soluble Tumor Necrosis Factor Receptor: Enbrel® (Etanercept) for the Treatment of Acute Non-Infectious Pulmonary Dysfunction (Idiopathic Pneumonia Syndrome) Following Allogeneic Stem Cell Transplantation [NCT00309907]Phase 239 participants (Actual)Interventional2006-04-30Completed
A Randomized Phase 3 Study of Brentuximab Vedotin (SGN-35) for Newly Diagnosed High-Risk Classical Hodgkin Lymphoma (cHL) in Children and Young Adults [NCT02166463]Phase 3600 participants (Actual)Interventional2015-03-19Active, not recruiting
Swiss PACK-CXL (Photoactivated Chromophore for Infectious Keratitis Cross-linking) Multicenter Trial for the Treatment of Infectious Keratitis [NCT02717871]Phase 335 participants (Actual)Interventional2016-03-31Completed
Intensified Tyrosine Kinase Inhibitor Therapy (Dasatinib NSC# 732517) in Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (ALL) [NCT00720109]Phase 2/Phase 363 participants (Actual)Interventional2008-07-14Completed
Evaluation of Inhaled Corticosteroid Treatment in Sinusitis [NCT01907204]Phase 2/Phase 350 participants (Actual)Interventional2013-07-31Completed
Relative Efficacy of Repeat Course of Intravenous methyLprednisolone and Intramuscular ACTH in the Treatment of Acute Relapse of Multiple Sclerosis After Sub Response to Initial Course of Intravenous Methylprednisolone (RECLAIM): a Single Center Pilot Stu [NCT00947895]Phase 2/Phase 330 participants (Actual)Interventional2009-10-31Terminated(stopped due to Study reached halfway point in approximately one year time period and was halted to analyze data.)
[NCT00000147]0 participants Interventional1988-07-31Active, not recruiting
Acute Respiratory Distress Syndrome Clinical Network (ARDSNet) [NCT00000579]Phase 30 participants Interventional1994-09-30Completed
A Controlled Randomized Trial to Study the Efficacy of Adjunctive Methylprednisolone for the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Pediatric AIDS Patients [NCT00000741]Phase 30 participants (Actual)InterventionalWithdrawn
"Efficacy of Infliximab as Bridging Therapy in the Treatment of Patients Affected by Corticodependent Crohn's Disease Under Standard Treatment With Azathioprine" [NCT00796250]Phase 39 participants (Actual)Interventional2003-11-01Terminated(stopped due to Due to poor patient recruitment, a decision was made to terminate this trial.)
Intérêt de la corticothérapie Dans la Pneumocystose Grave du Patient immunodéprimé Non VIH. Essai Prospectif Multicentrique Randomisé Contrôlé : PIC [NCT02944045]Phase 3222 participants (Anticipated)Interventional2017-02-15Recruiting
Efficacy of Methylprednisolone in Severe Community-acquired Pneumonia，A Multi-center Randomized Controlled Trial [NCT02552342]Phase 4610 participants (Anticipated)Interventional2015-05-31Recruiting
Acute Unilateral Vestibulopathy and Corticosteroid Treatment [NCT02912182]Phase 478 participants (Actual)Interventional2015-12-31Terminated(stopped due to Placebo medication expired)
Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas [NCT01024322]1,189 participants (Actual)Observational2009-10-01Terminated(stopped due to Terminated to initiate FDA IND-cleared study protocol)
Utility of Intramuscular Corticosteroids for Radicular Low Back Pain [NCT00290589]Phase 382 participants (Actual)Interventional2003-06-30Completed
Local Injection of Ozone Versus Methylprednisolone Acetate in Carpal Tunnel Syndrome of Scleroderma Patients. A Single-blind Randomized Clinical Trial [NCT03742466]50 participants (Actual)Interventional2018-11-10Completed
A Randomised Evaluation of Molecular Guided Therapy for Diffuse Large B-cell Lymphoma With Bortezomib [NCT01324596]Phase 31,132 participants (Actual)Interventional2011-04-30Completed
A Randomized, Multicenter, Open-label, 6-month Study to Explore the Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Combination With Two Corticosteroid Regimens for the Treatment of Lupus Nephritis Flare [NCT00423098]Phase 281 participants (Actual)Interventional2007-02-28Completed
An Open-label, Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of Chronic Graft Versus Host Disease After TLI/ARG Nonmyeloablative Allogeneic Stem Cell Transplantation [NCT00186628]Phase 236 participants (Actual)Interventional2005-06-30Completed
Safety and Feasibility of Umbilical Cord Blood Cell Transplant Into Injured Spinal Cord: an Open-Labeled, Dose-Escalating Clinical Tiral [NCT01046786]Phase 1/Phase 28 participants (Actual)Interventional2010-01-31Completed
An Oral Methylprednisolone Taper Within a Multimodal Analgesic Regimen After Total Knee Arthroplasty: a Double-Blind Randomized Placebo-Controlled Trial [NCT05097976]Phase 4420 participants (Anticipated)Interventional2022-03-01Recruiting
Evaluation of the Effect of Octreotide Compared to Placebo in Patients With Inoperable Bowel Obstruction Due to Peritoneal Carcinomatosis [NCT00332696]Phase 264 participants (Actual)Interventional2005-09-30Completed
A Randomized Trial of Rituximab in Induction Therapy for Living Donor Renal Transplantation [NCT01095172]Phase 4100 participants (Actual)Interventional2010-11-30Active, not recruiting
High Dose Cyclophosphamide & ATG With Hematopoietic Stem Cell Transplantation in Patients With Refractory Idiopathic Inflammatory Myopathy Diseases: A Phase I Trial [NCT00278564]Phase 17 participants (Actual)Interventional2005-09-30Terminated(stopped due to high relapse rate)
An Open-Label, Phase 1 Study to Examine the Pharmacokinetic Interactions Between VX-509 and Prednisone or Methylprednisolone in Healthy Male Subjects [NCT01886209]Phase 128 participants (Anticipated)Interventional2013-06-30Completed
Assessing the Efficacy of DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert, When Placed Within the Lower Eye Lid Canaliculus in Comparison to Topical Prednisolone Acetate Following Bilateral Small Incision Lenticule Extraction (SMILE) [NCT04380857]Phase 420 participants (Actual)Interventional2020-06-18Completed
A Phase II Study to Evaluate Low-Dose Alemtuzumab as a Glucocorticoid-Sparing Agent for Initial Systemic Treatment of Acute Graft-Versus-Host Disease [NCT00410657]Phase 253 participants (Anticipated)Interventional2006-07-31Completed
Macular Edema Nepafenac vs. Difluprednate Uveitis Trial [NCT01939691]Phase 49 participants (Actual)Interventional2018-09-12Terminated(stopped due to Difficulty enrolling)
Lessdrops™ Prophylactic Treatment After Routine Phacoemulsification Compared to Standard Drops Regimen [NCT03578276]Phase 435 participants (Actual)Interventional2018-06-22Completed
A Double-blind, Two-arm, Multicenter, Randomized Trial to Evaluate Efficacy of Cyclophosphamide Versus Methylprednisolone in Patients With Recent Secondary Progressive Multiple Sclerosis: P.R.OM.E.S.S Study [NCT00241254]Phase 3138 participants (Actual)Interventional2005-12-31Completed
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Itolizumab in Subjects With Newly Diagnosed Acute Graft Versus Host Disease [NCT05823675]Phase 144 participants (Anticipated)Interventional2023-05-19Recruiting
Phase II Study of High-dose Methylprednisolone and Rituximab in Previously Treated Patients With High Risk Chronic B Lymphocytic Leukemia [NCT00558181]Phase 229 participants (Actual)Interventional2007-09-30Completed
European Multicenter and Open-Label Controlled Randomized Trial to Evaluate the Efficacy of Sequential Treatment With Tacrolimus-Rituximab Versus Steroids Plus Cyclophosphamide in Patients With Primary Membranous Nephropathy (The STARMEN Study) [NCT01955187]Phase 386 participants (Actual)Interventional2014-01-31Completed
Steroid Injections vs. Platelet Rich Plasma Injections in Patients With Plantar Fasciitis: A Comparison of Clinical and Ultrasound Findings [NCT01957631]Phase 2/Phase 30 participants (Actual)Interventional2013-06-30Withdrawn(stopped due to Lack of funding)
A Randomized Trial of Intravenous Pulse Versus Sequential Steroid Therapy for Patients With Graves' Orbitopathy [NCT01969019]Phase 470 participants (Anticipated)Interventional2010-01-31Recruiting
Antiemetic Corticosteroid Rotation From Dexamethasone to Methylprednisolone to Prevent Dexamethasone-Induced Hiccup in Cancer Patients Treated With Chemotherapy: A Randomized, Single-Blind, Crossover Phase III Trial [NCT01974024]Phase 365 participants (Actual)Interventional2013-10-01Completed
A Prospective Randomized 3-arm Trial Comparing Intra-articular Corticosteroid Injection vs Arthrographic Distention vs Arthrographic Distention Plus Intra-articular Corticosteroid Injection in the Treatment of Adhesive Capsulitis [NCT01983527]132 participants (Anticipated)Interventional2013-12-31Not yet recruiting
Comparing the Effectiveness of Steroid Injection Versus Placebo and Immobilization Versus no Immobilization in Treating Patients With Lateral Epicondylitis [NCT01986465]Phase 2/Phase 378 participants (Actual)Interventional2013-05-31Completed
Multicenter, Randomized, Double-blind Clinical Trial to Compare the Clinical and Radiological Efficacy of 625 mg Versus 1250 mg of Oral Methylprednisolone in Patients With Multiple Sclerosis in Relapse. [NCT01986998]Phase 449 participants (Actual)Interventional2013-10-31Completed
Comparison of Efficacy of Dexamethasone and Methylprednisolone in Moderate to Severe Covid 19 Disease [NCT04603729]Phase 3100 participants (Actual)Interventional2020-05-30Completed
PhaseIV Study of Intra-articular Methylprednisolone in TMJ Arthralgia [NCT01995019]Phase 456 participants (Actual)Interventional2013-12-10Completed
Comparison of the Efficacy of Different Steroids in the Treatment of Abnormal Scars (Keloids, Hypertrophic Scars) [NCT04593706]40 participants (Anticipated)Interventional2020-11-01Not yet recruiting
Preoperative Glucocorticoid Use in Major Hepatectomy - A Randomized Controlled Trial [NCT01997658]Phase 2/Phase 3200 participants (Actual)Interventional2014-10-31Completed
High Doses of Methylprednisolone in the Management of Caustic Esophageal Burns in Children [NCT02002078]Phase 483 participants (Actual)Interventional2007-02-28Completed
Efficacy of the Intralesional Infusion of Local Anesthetic and Steroids After Major Abdominal Surgery: a Randomized Double Blind Phase III Trial [NCT02002663]Phase 3120 participants (Actual)Interventional2013-08-31Completed
Randomised, Multicentre, Open Label, Parallel Group Pragmatic Clinical Trial of Local Steroid Injection Versus Night Splinting in Mild to Moderate Carpal Tunnel Syndrome (CTS) [NCT02038452]Phase 4234 participants (Actual)Interventional2014-04-30Completed
Influence of Corticoids on Renal Function in Cardiac Surgery [NCT00879931]Phase 280 participants (Actual)Interventional2013-01-31Completed
Do Intraoperative Topical Corticosteroids Aid in the Prevention of Postoperative Dysphagia Following Elective Anterior Cervical Discectomy and Fusion? A Randomized, Controlled, Double Blinded Clinical Trial [NCT02539394]128 participants (Actual)Interventional2015-08-31Completed
Efficacy and Safety of Two Glucocorticoid Regimens in the Treatment of Sarcoidosis: a Randomized Controlled Trial [NCT03265405]Phase 486 participants (Actual)Interventional2017-04-01Completed
Efficacy and Safety of Difluprednate Ophthalmic Emulsion vs. a Fixed-Combination of Prednisolone Acetate - Phenylephrine Ophthalmic Suspension on Post-operative Inflammation Following Cataract Surgery. [NCT04631315]Phase 4255 participants (Actual)Interventional2019-03-24Completed
Study on the Association Between the Effect of Glucocorticoid Pulse Therapy on Neuromyelitis Optica and Gene Polymorphism: a Cohort Study [NCT04601142]350 participants (Anticipated)Observational2020-10-31Recruiting
Peking University Third Hospital Medical Science Research Ethics Committee [NCT04590183]30 participants (Anticipated)Interventional2020-10-01Recruiting
A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Clinical Effect of Laquinimod in Active Lupus Nephritis Patients, in Combination With Standard of Care (Mycophenolate Mofetil and Steroid [NCT01085097]Phase 246 participants (Actual)Interventional2010-09-01Completed
Cadaveric Organ Donor Management: Thyroid and Adrenocortical Hormone Replacement [NCT04528797]199 participants (Actual)Interventional2010-09-02Completed
A Phase 3 Multicenter, Randomized, Double-Masked Study of the Safety and Efficacy of Difluprednate 0.05% Ophthalmic Emulsion Compared to Prednisolone Acetate 1% Ophthalmic Suspension in the Treatment of Endogenous Anterior Uveitis [NCT01201798]Phase 3111 participants (Actual)Interventional2010-10-31Completed
Comparison of the Efficacy Between Ultrasound-guided Dextrose Injection Versus Dextrose With Methylprednisolone Injection in Patients With Carpal Tunnel Syndrome: a Prospective, Randomized Double-blind Clinical Trial. [NCT06045013]Phase 370 participants (Anticipated)Interventional2023-09-13Recruiting
Ultrasound Guided Sacroiliac Joint Injections With Ketorolac Versus Corticosteroid: A Prospective Non-inferiority Study [NCT06081101]Early Phase 180 participants (Anticipated)Interventional2024-01-31Not yet recruiting
Risk Stratification-directed Low-dose Glucocorticoid Prophylaxis for Acute GVHD After Unmanipulated Haploidentical Blood and Marrow Transplantation--a Randomized, Controlled, Clinical Trial [NCT01607580]145 participants (Actual)Interventional2012-06-30Completed
Evaluation of the Bioavailability of Methylprednisolone Succinate Administered Intranasally [NCT05649878]8 participants (Actual)Interventional2021-11-05Completed
Non-Invasive Mechanical Ventilation in Elderly Patients Affected by Acute Hypercapnic Respiratory Failure:A Randomized Control Study vs Standard Medical Therapy A Multicentric Randomized Controlled Trial [NCT00600639]Phase 482 participants (Actual)Interventional2004-01-31Terminated
Intracanalicular Dexamethasone Insert for Post-Corneal Cross-Linking Inflammation and Pain- The LINK Study [NCT04168112]Phase 420 participants (Actual)Interventional2020-02-12Completed
Incretin Physiology and Beta-Cell Function Before and After Treatment With Steroid Hormone in Healthy Individuals [NCT00713440]10 participants (Actual)Interventional2008-07-31Completed
A Comparison of Intravenous Versus Oral Administration of Prednisolone in the Treatment of Exacerbations of Chronic Obstructive Pulmonary Disease [NCT00311961]Phase 4256 participants Interventional2001-06-30Completed
A Phase 2 Study of SNDX-5613 in Combination With Chemotherapy for Patients With Relapsed or Refractory KMT2A-Rearranged Infant Leukemia [NCT05761171]Phase 278 participants (Anticipated)Interventional2023-11-20Recruiting
Preoperative Methylprednisolone to Patients Suspected of Appendicitis Undergoing Laparoscopy [NCT02711449]Phase 278 participants (Actual)Interventional2016-04-30Completed
An Open-label Multicenter Trial to Study the Efficacy and Safety of Caplacizumab in Japanese Patients With Acquired Thrombotic Thrombocytopenic Purpura [NCT04074187]Phase 2/Phase 321 participants (Actual)Interventional2019-10-21Completed
Randomized Trial of Plasma Exchange as Adjunctive Therapy for Severe Crescentic GlomerUlonephritis of IgA NEphropathy (RESCUE Study) [NCT02647255]Phase 2/Phase 310 participants (Actual)Interventional2016-03-31Terminated(stopped due to Due to the rarity and rapid progressive course of the disease, patients were less likely to participate in randomization.)
The Role of Anterior Segment Optical Coherence Tomography in Management of Acquired Punctal Stenosis [NCT04318652]Phase 480 participants (Actual)Interventional2018-09-02Completed
Evaluation of High-dose Corticosteroids on Microcirculation Alterations in Cardiac Surgery, by FMD (Flow Mediated vasoDilation), Near Infrared Spectrophotometry (NIRS) and Biological Analysis (Syndecan-1) [NCT02798068]Phase 460 participants (Anticipated)Interventional2016-05-31Recruiting
A Randomized Controlled Clinical Trial on the Efficacy and Safety of Glucocorticosteroid in the Patients With Chronic Recurrent Drug-induced Liver Injury [NCT02651350]Phase 1/Phase 280 participants (Actual)Interventional2015-12-31Completed
Efficacy of Intra-operative Subacromial Corticosteroid Injections on Surgical Outcomes After Arthroscopic Shoulder Surgery [NCT02867904]Phase 412 participants (Actual)Interventional2016-03-31Terminated(stopped due to It was difficult to recruit patients to get the appropriate sample size.)
Comparison of Corticosteroids Versus Placebo on Duration of Ventilatory Support During Severe Acute Exacerbations of COPD Patients in the Intensive Care Unit: a Multicentre Randomized Controlled Trial [NCT04163536]Phase 3440 participants (Anticipated)Interventional2021-10-25Recruiting
Randomized, Placebo-Controlled Trial of Bilateral 3rd/4th Common Digital Foot Nerve Injections to Treat Restless Legs Syndrome [NCT00656110]60 participants (Anticipated)Interventional2008-04-30Recruiting
Desensitization for Preformed Anti-HLA Antibodies in Kidney Transplantation [NCT00908583]Phase 444 participants (Actual)Interventional2009-05-31Completed
Corticosteroids for Cancer Pain [NCT00676936]Phase 350 participants (Actual)Interventional2008-04-30Completed
Phase 1, Open-label, Randomized, Single-dose, 2-treatment, 2 Period Crossover Bioequivalence Study Comparing Constituted Methylprednisolone Powder For Oral Suspension 4 Mg/ml To Methylprednisolone 32 Mg Tablet Under Fasted Conditions [NCT01405131]Phase 10 participants (Actual)Interventional2012-01-01Withdrawn
Phase 1, Open-label, Randomized, Single-dose, 2-treatment, Crossover Be Study Comparing Constituted Methylprednisolone Powder For Oral Suspension 4 Mg/ml To Methylprednisolone 32 Mg Tablet Under Fed Conditions [NCT01405170]Phase 10 participants (Actual)Interventional2011-10-14Withdrawn
Assessment of Corticosteroid Effect in the Prevention of Facial Palsy After Cerebella-pontine Angle Surgery [NCT00438087]Phase 3313 participants (Actual)Interventional2007-03-31Completed
Retrospective Study of Intrapleural Methylprednisolone Injection for Multiple Organ Failure With Acute Respiratory Distress Syndrome [NCT01423864]Phase 229 participants (Actual)Interventional2005-06-30Completed
Comparison Between Prednisolone and Dexamethasone on D28 Mortality in Patients on Oxygen Therapy, With CoViD-19: Multicenter, Randomized, Open-label Non-inferiority Study [NCT04765371]Phase 389 participants (Actual)Interventional2021-03-03Completed
A Randomized, Multicentre, Double-blind Study to Evaluate the Efficacy of High-dose Administration of Methylprednisolone in Addition to Standard Treatment, in SARS-CoV2 (COVID-19) Pneumonia Patients [NCT04673162]Phase 3260 participants (Actual)Interventional2020-12-17Completed
Efficacy of High-dose Corticosteroid Pulses Added to Conventional Oral Corticosteroid Course for Moderate Flares of Ulcerative Colitis. [NCT02921555]Phase 475 participants (Actual)Interventional2018-10-11Completed
Assessing the Efficacy and Safety of DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert, When Placed Within the Lower Eye Lid Canaliculus in Pseudo Phakic Patients Undergoing Gas Bubble Repair and Laser Following Retinal Detachment [NCT04464629]Phase 47 participants (Actual)Interventional2020-07-14Terminated(stopped due to Poor enrollment)
A Randomized, Parallel-Cohort Phase 1 Study of Itacitinib in Combination With Corticosteroids for the Treatment of Acute Graft Versus Host Disease [NCT02614612]Phase 131 participants (Actual)Interventional2015-12-31Completed
Evaluation of the Tolerability and Efficacy of Erythropoietin (EPO) Treatment in Spinal Shock: Comparative Study VS Methylprednisolone (MP) [NCT00561067]Phase 310 participants (Actual)Interventional2008-04-30Terminated(stopped due to Italian Medicines Agency decision)
Double-Blind, Placebo Controlled, Randomized, Multicenter, Parallel-Group Study to Compare the Efficacy and Safety of Advantan Cream Twice Weekly With Advabase Cream During a Maintenance Phase of 16 Weeks After Successful Treatment of Atopic Dermatitis Wi [NCT00185510]Phase 4250 participants (Actual)Interventional2005-03-31Completed
Can Montelukast Shorten Corticosteroid Therapy In Children With Mild To Moderate Acute Asthma? [NCT00213252]Phase 2130 participants (Actual)Interventional2005-09-30Completed
Multisystem Inflammatory Syndrome Therapies in Children (MISTIC) Comparative Effectiveness Study [NCT04898231]Phase 2/Phase 3180 participants (Anticipated)Interventional2020-12-22Active, not recruiting
A Phase 1, Open-Label, Randomized, Single-Dose, 3-Treatment, Crossover Bioavailability Study Comparing Constituted Methylprednisolone Powder For Oral Suspension 4 Mg/Ml to Methylprednisolone 32 Mg Tablet Under Fasted Conditions [NCT01267201]Phase 124 participants (Actual)Interventional2010-11-30Completed
Comparison of the Effectiveness of the Ultrasound Guided Subacromial, Acromioclavicular With Subacromial Injection and Suprascapular Nerve Block in Patients With Shoulder Impingement Syndrome ; A Randomized Controlled, Single Blind, Clinical Trial [NCT05015322]Phase 488 participants (Actual)Interventional2017-01-01Completed
Use of Topical Euphrasia, a Homeopathic Remedy in Ophthalmology [NCT02416128]0 participants (Actual)Interventional2015-04-30Withdrawn(stopped due to No participants enrolled)
A Two-Part, Multi-Center, Prospective, Phase 2/3 Clinical Study to Evaluate the Safety and Efficacy of GLASSIA as an Add-On Biopharmacotherapy to Conventional Steroid Treatment in Subjects With Acute Graft-Versus-Host Disease With Lower Gastrointestinal I [NCT02956122]Phase 2/Phase 31 participants (Actual)Interventional2017-04-26Terminated(stopped due to The decision to discontinue the study was based on business reasons.)
Oral Prednisolone Dosing in Children Hospitalized With Asthma [NCT00257933]Phase 4152 participants (Actual)Interventional2006-02-28Completed
[NCT00000138]Phase 30 participants Interventional1989-05-31Active, not recruiting
Phase IV Study of Perioperative Steroid's Effects on Death or MI in High-Risk Patients Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass [NCT00427388]Phase 47,507 participants (Actual)Interventional2007-06-30Active, not recruiting
[NCT00480675]65 participants (Actual)Interventional2007-03-31Completed
[NCT00469781]Phase 495 participants (Actual)Interventional2007-05-31Completed
[NCT00501579]Phase 30 participants InterventionalCompleted
A Randomized, Masked Multi-center Safety & Efficacy Study of the Effects of Preoperative & Postoperative Cataract Surgery Use of Difluprednate Ophthalmic Emulsion, 0.05% Compared to Prednisolone Acetate Ophthalmic Suspension 1% on Visual Acuity & Corneal [NCT01244334]Phase 452 participants (Actual)Interventional2009-03-31Completed
A Multicenter, Double-blinded, Randomized, Placebo-controlled Trial to Compare the Effectiveness of Intratympanic Injections methylPREDnisolon Versus Placebo in the Treatment of Vertigo Attacks in MENière's Disease (PREDMEN Trial). [NCT05851508]Phase 3148 participants (Anticipated)Interventional2023-10-01Recruiting
Prednisolone and Vitamin B1, B6, and B12 in Patients With Post-COVID-19-Syndrome (PC19S) - a Randomized Controlled Trial in Primary Care [NCT05638633]Phase 3340 participants (Anticipated)Interventional2022-11-11Recruiting
A Groupwide Pilot Study to Test the Tolerability and Biologic Activity of the Addition of Azacitidine (NSC# 102816) to Chemotherapy in Infants With Acute Lymphoblastic Leukemia (ALL) and KMT2A (MLL) Gene Rearrangement [NCT02828358]Phase 278 participants (Actual)Interventional2017-04-01Active, not recruiting
Mesenchymal Stem Cells Under Basiliximab/Low Dose RATG to Induce Renal Transplant Tolerance [NCT00752479]Phase 1/Phase 24 participants (Actual)Interventional2008-05-31Terminated(stopped due to Necessity of major revision of the protocol)
Remission Induction in Very Early Rheumatoid Arthritis: a Comparison of Etanercept Plus Methotrexate Plus Steroid With Standard Therapy [NCT00523692]Phase 420 participants (Anticipated)Interventional2007-09-30Not yet recruiting
A Multicentre Placebo-Controlled Evaluation of Prednisolone and/or Valaciclovir for the Treatment of Bell's Palsy [NCT00510263]Phase 4839 participants (Actual)Interventional2001-05-31Completed
The Evaluation of the Safety and Efficacy of Sustained Release Dexamethasone Intracanalicular Insert (DEXTENZA) in Pediatric Patients Following Retinal Surgery or Laser Treatment Under Anesthesia (TENDER) [NCT05620901]Early Phase 130 participants (Anticipated)Interventional2023-02-01Recruiting
Nivolumab With Standard of Care Chemotherapy for the First Line Treatment of Peripheral T Cell Lymphoma [NCT03586999]Phase 1/Phase 218 participants (Actual)Interventional2018-11-07Active, not recruiting
A Phase III Study of Risk Directed Therapy for Infants With Acute Lymphoblastic Leukemia (ALL): Randomization of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition (CEP-701, Lestaurtinib; NSC#617807) [NCT00557193]Phase 3218 participants (Actual)Interventional2008-01-15Active, not recruiting
Effects of Glucocorticoids on Craving During Detoxification Treatment of Heroin and/or Stimulants [NCT02935101]Phase 24 participants (Actual)Interventional2016-10-31Terminated(stopped due to difficulties in recruiting study participants)
Pilot Study Investigating the Utility of Epidural AlloGen-LI Injection for Treatment of Spinal Stenosis Symptoms [NCT02932020]0 participants (Actual)Interventional2016-10-31Withdrawn
Clinical and Radiological Comparison of the Efficacy of Hyaluronic Acid, PRP and Steroid Injections in Partial Rotator Cuff Tears: A Prospective Randomized Study [NCT04681937]80 participants (Anticipated)Interventional2021-06-01Not yet recruiting
High-Dose Corticosteroids for Immune Reconstitution Inflammatory Syndrome in Patients Who Develop Progressive Multifocal Leukoencephalopathy on Natalizumab [NCT01211665]Phase 43 participants (Actual)Interventional2010-09-30Terminated(stopped due to This study was stopped prematurely due to lack of enrollment within a 1-5-year period.)
DEXTENZA for the Treatment of Post-Surgical Pain and Inflammation ComparEd to StandaRd of Care Topical Cortico-Steroid Treatment In PatientS Who Undergo BilaTeral Pterygium Surgery PERSIST Study [NCT04351737]Phase 420 participants (Anticipated)Interventional2020-07-15Active, not recruiting
Comparison of the Efficacy and Safety of Two Corticosteroid Regimens in the Treatment of Diffuse Lung Disease After Coronavirus Disease 2019 (COVID-19) Pneumonia [NCT04657484]130 participants (Actual)Interventional2020-12-01Completed
A PedAL/EuPAL Phase 1/2 Trial of IMGN632 in Pediatric Patients With Relapsed or Refractory Leukemia [NCT05320380]Phase 1/Phase 20 participants (Actual)Interventional2023-08-01Withdrawn(stopped due to Withdrawn per CS0150757)
Effects of Peri-Operative Glucosteroid Administration on Outcomes Following Distal Radius Fracture [NCT05655130]Phase 160 participants (Anticipated)Interventional2018-11-06Active, not recruiting
An Open-label, Single-arm Study to Describe Glucocorticoid Use in Rheumatoid Arthritis Patients Treated With Tocilizumab in Daily Clinical Practice and to Evaluate Systematic Glucocorticoid Dose Reduction Once Low Disease Activity is Reached (ACT-ALONE) [NCT01219933]Phase 468 participants (Actual)Interventional2011-01-31Completed
[NCT00854061]Phase 3172 participants (Actual)Interventional2009-02-28Completed
Autologous Followed by Non-myeloablative Allogeneic Transplantation for Non-Hodgkin's Lymphoma [NCT00882895]Phase 218 participants (Actual)Interventional2009-05-05Active, not recruiting
Prophylactic Corticosteroid to Prevent COVID-19 Cytokine Storm [NCT04355247]Phase 220 participants (Anticipated)Interventional2020-04-14Recruiting
Matched Unrelated and Haploidentical Bone Marrow Transplantation for Hematologic Malignancies [NCT00003960]Phase 236 participants (Anticipated)Interventional1998-04-30Completed
A Phase II Study to Evaluate Efficacy and Tolerability of Methotrexate in Combination With Glucocorticoids for the Treatment of Newly Diagnosed Acute Graft-Versus-Host Disease After Nonmyeloablative Hematopoietic Cell Transplantation [NCT00357084]Phase 253 participants (Anticipated)Interventional2006-05-31Completed
Research on the Treatment of Severe Community-acquired Pneumonia in Children [NCT05768204]Phase 4160 participants (Anticipated)Interventional2023-03-10Recruiting
Open Randomized Study on the Efficacy of corticoïd Infiltration Versus Physiological Solution Infiltration Versus Feigning of Infiltration Via Sacro-coccygien Hiatus Versus Natural Evolution in Discal Sciatica [NCT01482897]Phase 313 participants (Actual)Interventional2011-12-31Terminated(stopped due to Enrolment stopped on December 01, 2014 since after 3 years, only 13 patients were included (instead of 274) (Date of last visit last patient : October 3, 2013).)
Urinary Aquaporin 2 Excretion After Methylprednisolone in Fasting Healthy Humans [NCT00281710]Phase 420 participants Interventional2005-10-31Completed
Prospective Phase II Study of Early Low Dose Steroid Therapy of Acute Respiratory Distress Syndrome (ARDS) After Thoracic Surgery (E-START) [NCT00290602]Phase 240 participants Interventional2004-02-29Completed
Does a Single Steroid Injection Reduce the Formation of Postmastectomy Seroma [NCT00307606]Phase 440 participants (Anticipated)Interventional2005-12-31Recruiting
The Efficacy and Safety of Intravenous Pulse Steroids Compared to Standard Oral Steroids in the Treatment of Problematic Hemangiomas in Infants: A Randomized Controlled Trial [NCT00312520]Phase 320 participants Interventional2002-07-31Completed
Effect of Intravenous Methylprednisolone and Intravenous Erythropoietin in Toxic Optic Neuropathies: Randomized Clinical Trial. [NCT05748561]Phase 2/Phase 318 participants (Anticipated)Interventional2022-04-05Recruiting
Genomic Effects of Glucocorticoids in Patients With Systemic Lupus Erythematosus [NCT04233164]Early Phase 147 participants (Actual)Interventional2020-03-04Active, not recruiting
A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Treatment [NCT05665270]Phase 440 participants (Anticipated)Interventional2023-01-30Enrolling by invitation
[NCT00433225]Phase 40 participants InterventionalCompleted
A Masked Comparison of Acular LS Plus Steroid Versus Steroid Alone for the Prevention of Macular Leakage in Cataract Patients [NCT00348244]Phase 40 participants InterventionalCompleted
A Multi-Center, Randomized, Blinded, Parallel-Group Study of AVONEX Compared With AVONEX in Combination With Oral Methotrexate, Intravenous Methylprednisolone, or Both in Subjects With Relapsing Remitting MS Who Have Breakthrough Disease on AVONEX Monothe [NCT00112034]Phase 4350 participants Interventional2003-06-30Completed
Double-Blind Randomized Placebo-Controlled Trial on Clinical and Biological Effects of Oral Corticosteroids or Doxycyclin in Patients With Nasal Polyposis [NCT00480298]Phase 248 participants Interventional2002-11-30Completed
A Multicenter, Randomized, Open Label, Parallel Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Combination With MMF and Steroids in Patients Undergoing Kidney Transplantation and a Pharmacokinetics Study. [NCT00481819]Phase 3240 participants (Actual)Interventional2007-07-31Completed
The Effect of 6-Methyl-Prednisolone on Organ Dysfunction and Mortality of Patients With Unresolving Multiple Organ Dysfunction Syndrome [NCT00127985]Phase 4240 participants (Anticipated)Interventional2005-08-31Recruiting
A Randomised, Placebo-controlled, Parallel Group Single Dose Study of SB681323 in Patients With Active RA to Investigate the CRP Dose Response Relationship [NCT00134693]Phase 277 participants (Actual)Interventional2005-06-21Completed
Medication Overuse Headache: A Randomised Double Blind Study of Prednisolone or Placebo in Withdrawal Therapy (Phase 3), and a Randomised 1 Year Follow up by Neurologist or General Physician After Successful Withdrawal Therapy [NCT00135122]Phase 3100 participants (Actual)Interventional2003-09-30Completed
Assessment of the Efficacy of Glucocorticoids in Improving Post-operative Organ Dysfunction in Patients With Acute Type A Aortic Dissection(GLAD): a Randomized Controlled Trial [NCT05329740]Phase 4212 participants (Actual)Interventional2022-02-07Completed
Repeated Corticosteroid Injections Around the Greater Occipital Nerve (GON) as Prophylactic Treatment in Chronic Cluster Headache [NCT05324748]Phase 350 participants (Anticipated)Interventional2022-11-07Recruiting
A Phase I Randomized, Double-blind, Placebo-controlled, Dose-increasing Single Dose Study Evaluating the Safety, Tolerability，Pharmacokinetics and Pharmacodynamics Analysis of Pegloticase in Subjects With Asymptomatic Hyperuricemia [NCT05302388]Phase 145 participants (Actual)Interventional2022-04-11Completed
A Randomized Phase 3 Trial of Nivolumab (NSC# 748726) in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma [NCT04759586]Phase 3244 participants (Anticipated)Interventional2021-10-05Recruiting
The Effect of Corticosteroids on Inflammation at the Edge of Acute Multiple Sclerosis Plaques: An Investigator-Blinded Study [NCT02784210]Phase 230 participants (Anticipated)Interventional2016-10-05Recruiting
A Randomized, Multicenter, Open-Label Study of Single Dose Filgrastim-SD/01 Versus Daily Filgrastim Following ESHAP Chemotherapy for Non-Hodgkin's Lymphoma [NCT00004192]Phase 260 participants (Anticipated)Interventional2000-05-01Completed
Trial of High Dose Immunosuppressive Therapy With Hematopoietic Stem Cell Support in Devic's Disease [NCT00787722]Phase 1/Phase 213 participants (Actual)Interventional2009-10-10Completed
Phase II Study of Combination of Thymoglobulin, Cyclosporine, Methylprednisone, and Granulocyte Colony-stimulating Factor (GCSF) in Patients With Newly Diagnosed Aplastic Anemia or With Hypoplastic or Low/Intermediate-1 Risk Myelodysplastic Syndrome [NCT00806598]Phase 253 participants (Actual)Interventional2005-05-31Completed
A Prospective Randomized Controlled Trial of Early Non-Invasive Positive Pressure Ventilation in Patients With Hypoxemic Respiratory Failure and Malignancies [NCT02464696]256 participants (Anticipated)Interventional2015-10-06Recruiting
Lymphodepleting Chemotherapy and T-Cell Suppression Followed By Allogeneic Natural Killer Cells and IL-2 in Patients With Recurrent Ovarian, Fallopian Tube, Primary Peritoneal Cancer and Advanced Metastatic Breast Cancer (MT2009-30) [NCT01105650]Phase 213 participants (Actual)Interventional2010-07-31Completed
Injection of Dorsal Scapular n at Different Levels, Dose it Make Difference? [NCT04693312]Phase 2/Phase 360 participants (Actual)Interventional2020-01-01Completed
A Phase 2 Randomized, Investigator-Masked, Comparator-controlled Trial to Evaluate the Safety and Efficacy of NS2 Eye Drops in Patients With Anterior Uveitis [NCT02406209]Phase 245 participants (Actual)Interventional2015-03-31Completed
Multi-center, Randomized, Double Masked, Vehicle Controlled Phase IV Study to Compare the Efficacy, Ocular Safety and Tolerability of a Two Day Treatment With Eye Drops (0.5% Prednisolone Acetate, One Drop Four Times Per Day) in Patients With Intraocular [NCT00170729]Phase 462 participants (Actual)Interventional2004-08-17Completed
The Impact of Pre-emptive Large Doses of Methylprednisolone Combined With Gabapentin on Pain Treatment and Convalescence After Total Knee Arthroplasty in Elderly: A Double-blind Randomized Study [NCT04653415]Phase 4160 participants (Actual)Interventional2019-06-01Completed
A Phase 2b, Double-Blind, Three Arm, Randomized, Placebo Controlled Trial With Restricted Response Adaptive Randomization Testing the Efficacy and Safety of High Dose Methylprednisolone or Equine Anti-Thymocyte Globulin as Treatment for Acute Liver Failur [NCT04862221]Phase 2163 participants (Anticipated)Interventional2022-02-09Recruiting
Preoperative Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass [NCT00934843]77 participants (Actual)Interventional2007-03-31Completed
Gene Transfer for Patients With Fanconi Anemia Complementation Group A (FANCA) [NCT01331018]Phase 13 participants (Actual)Interventional2012-02-22Active, not recruiting
A Phase III Study to Determine Efficacy and Safety of Low-Dose Glucocorticoids for Initial Treatment of Acute Graft-versus-Host Disease [NCT00929695]Phase 3164 participants (Actual)Interventional2009-06-30Completed
CSP #574 - Evaluate the Safety and Efficacy of Methylprednisolone in Hospitalized Veterans With Severe Community-Acquired Pneumonia [NCT01283009]Phase 3584 participants (Actual)Interventional2012-01-09Completed
Comparison of Efficacy and Safety of Intravenous Pulsed Methylprednisolone and Oral Methotrexate Versus Intravenous Pulsed Methylprednisolone and Oral Placebo in the Treatment of Active Moderate and Severe Thyroid Eye Disease - a Prospective, Randomized, [NCT00348413]80 participants (Anticipated)Interventional2003-06-30Completed
A Randomized Controlled Trial to Evaluate the Efficacy and Safety of Docetaxel Combined With Platinum-based Drugs Compared With Docetaxel Alone for Metastatic Hormone-sensitive Prostate Cancer Patients Carrying DNA Repair Mutation [NCT05461261]Phase 250 participants (Anticipated)Interventional2022-07-01Recruiting
Efficacy and Safety of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 Chronic Kidney Disease [NCT05510323]Phase 3208 participants (Anticipated)Interventional2022-08-31Not yet recruiting
Pilot, Phase I, Single Blind Trial to Assess Itch Behavior in Nickel Sulphate Sensitized Volunteers. (PRURITUS- Nimpa Study). [NCT01529320]Phase 118 participants (Actual)Interventional2012-02-29Completed
Phase II Clinical Trial Incorporating Alemtuzumab (Campath-1H) in Combination With FK506 and Methylprednisolone for Treatment of Severe Acute Graft vs Host Disease [NCT00109993]Phase 234 participants (Actual)Interventional2005-01-31Completed
[NCT00000146]Phase 30 participants Interventional1988-07-31Active, not recruiting
Intratympanic Dexamethasone or Methylprednisolone for Sudden Hearing Loss as a Salvage Treatment: a Randomized, Double-blind, Multi-center Study [NCT04129697]30 participants (Anticipated)Interventional2020-01-01Not yet recruiting
[NCT00017628]Phase 120 participants Interventional2001-04-30Completed
A Phase III, Randomized, Placebo-Controlled, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Oral Beclomethasone 17, 21-Dipropionate (BDP) in Conjunction With Ten Days of High-Dose Prednisone Therapy in the Treatment of Patients With Gr [NCT00043147]Phase 30 participants Interventional2002-04-30Completed
A Phase II Study VEPEMB In Patients With Hodgkin's Lymphoma Aged ≥ 60 Years; Vinblastine, Cyclophosphamide, Procarbazine, Prednisolone, Etoposide, Mitoxantrone, and Bleomycin in Treating Older Patients With Hodgkin's Lymphoma [NCT00079105]Phase 2175 participants (Actual)Interventional2004-01-31Completed
Treatment of Patients With Membranous Nephropathy and Renal Insufficiency With Mycophenolate Mofetil and Prednisone: a Pilot Study [NCT00135967]Phase 2/Phase 330 participants Interventional2002-05-31Completed
Randomised, Double-Arm, Controlled, Open-Label Study Comparing Calcineurin Inhibitor-Free Immunosuppression (Zenapax®, CellCept® and Prednisolone) and Cyclosporine A Based Immunosuppression (Sandimmun Neoral®, CellCept® and Prednisolone) on the Outcome of [NCT00138970]Phase 470 participants Interventional2002-01-31Completed
A Prospective Randomized Open-label Study to Compare Mycophenolate Mofetil and A Prospective Randomized Open-label Study to Compare Mycophenolate Mofetil and Corticosteroid With Tacrolimus and Corticosteroid as Immunosuppressive Treatment for Lupus Membra [NCT00404794]Phase 320 participants (Anticipated)Interventional2005-11-30Completed
A Prospective Randomized Open-label Study to Compare Mycophenolate Mofetil and Corticosteroid With Conventional Immunosuppressive Treatment on Proteinuria in Idiopathic Membranous Nephropathy (MN) and Focal Segmental Glomerulosclerosis (FSGS) [NCT00404833]Phase 316 participants (Anticipated)Interventional2003-01-31Completed
Phase IV Study of Early RA: a Randomized Magnetic Resonance Imaging Study Comparing the Effects of Methotrexate Alone or in Combination With Infliximab or Intravenous Pulse Methylprednisolone [NCT00396747]Phase 445 participants (Actual)Interventional2003-06-30Completed
A Phase IV, Randomized, Multi-center Clinical Trial to Compare the Efficacy of Orbital Radiotherapy in Association With Intravenous Glucocorticoids vs Intravenous Glucocorticoids Alone for Moderately Severe and Active Graves' Orbitopathy [NCT03098225]Phase 4120 participants (Anticipated)Interventional2024-01-01Not yet recruiting
Induction Therapy for Lupus Nephritis With no Added Oral Steroids: An Open Label Randomised Multicentre Controlled Trial Comparing Oral Corticosteroids Plus Mycophenolate Mofetil (MMF) Versus Obinutuzumab and MMF [NCT04702256]Phase 3196 participants (Anticipated)Interventional2021-12-09Recruiting
Treatment of Acute Graft vs. Host Disease With Steroids Plus Daclizumab (Zenapax) or Placebo [NCT00053976]Phase 3105 participants (Actual)Interventional2001-01-31Completed
Single-Center, Randomized, Double Masked, Two-Period Cross-Over, Three Days Per Period, Phase IV Study to Compare Ocular Safety and Tolerability of Prednisolone Acetate 0.5% Eye Drops Versus Vehicle in Healthy Volunteers [NCT00134992]Phase 430 participants Interventional2004-08-31Completed
The Role of Topical Prednisolone Acetate Following Selective Laser Trabeculoplasty [NCT00406042]25 participants Interventional2005-09-30Completed
Dexamethasone Versus Methylprednisolone for the Treatment of Active Inflammatory Bowel Disease [NCT00152620]40 participants Interventional2004-06-30Terminated(stopped due to study completed)
A Phase I Trial of BBR 2778 in Combination With Cytarabine, Methylprednisolone and Cisplatin in the Treatment of Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma [NCT00053105]Phase 10 participants Interventional2002-02-28Active, not recruiting
A Multi-Center, Randomized, Double Masked, Bioequivalence Study of Tobramycin and Prednisolone Acetate (0.3/1.0%, ISTA) Ophthalmic Suspension Compared to PredForte (1.0% Prednisolone Acetate, Allergan) Ophthalmic Suspension [NCT00198523]Phase 3132 participants Interventional2005-07-31Completed
Prevention of Post-Extubation Laryngeal Edema With Intravenous Corticosteroids: a Prospective, Double-Blind, Placebo-Controlled Trial. [NCT00199576]Phase 3670 participants Interventional2000-12-31Completed
the Effect of Single Dose of Etomidate Used During Emergency Intubation on Hemodynamics and Adrenal Cortex: a Randomized Clinical Trial [NCT01792037]Phase 490 participants (Actual)Interventional2012-12-31Completed
Prospective Study on DEXTENZA® Safety And Efficacy Following Concomitant MIGS and Cataract Surgery [NCT04200651]Phase 425 participants (Actual)Interventional2020-01-13Completed
Randomized, Open-Label Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone With or Without Exemestane in Postmenopausal Women With ER+ Metastatic Breast Cancer Progressing After Letrozole or Anastrozole Therapy [NCT01381874]Phase 2297 participants (Actual)Interventional2011-08-24Completed
Peri-articular Injections Containing a Corticosteroid During Total Knee Arthroplasty [NCT00492973]101 participants (Actual)Interventional2006-03-31Completed
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy of CRx-102 in Subjects With Symptomatic Knee Osteoarthritis and Optional One-Year Extension [NCT00521989]Phase 2279 participants (Actual)Interventional2007-08-31Terminated(stopped due to CRx-102-006 study results, negative)
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Superiority of CRx-102 Over Each of Its Components When Given to Subjects With Active Rheumatoid Arthritis (RA) [NCT00551707]Phase 251 participants (Actual)Interventional2007-10-31Completed
A California Cooperative Clinical Study Comparing Allogeneic Hematopoietic Cell Transplantation Using Nonmyeloablative Host Conditioning With Total Lymphoid Irradiation and Anti-thymocyte Globulin Versus Best Standard of Care in Acute Myeloid Leukemia (AM [NCT00568633]Phase 358 participants (Actual)Interventional2007-08-31Terminated(stopped due to Poor accrual)
Adrenal Cortical Function and Vitamin A Deficiency in Sepsis, Severe Sepsis and Septic Shock: Prospective Randomized, Double Blind Placebo Controlled Clinical Trials [NCT03152474]Phase 4300 participants (Actual)Interventional1993-02-28Completed
Effect of Intraarticular Steroids on Bone Turnover in Osteoarthritis [NCT00682357]25 participants (Actual)Interventional2008-05-31Completed
Pilot Study of Methylprednisolone Replacement for Dexamethasone-induced Hiuup Patients [NCT01277731]0 participants (Actual)Interventional2010-07-31Withdrawn
Yale Steroid Enhanced Versus Exparel Nerveblock TKA Part 2 [NCT05736549]Phase 266 participants (Anticipated)Interventional2023-02-07Recruiting
[NCT00699803]Phase 264 participants (Actual)Interventional2008-05-31Completed
Azithromycin for Preventing the Development of Upper Respiratory Tract Illness Into Lower Respiratory Tract Symptoms in Children and Oral Corticosteroids for Treating Episodes of Significant Lower Respiratory Tract Symptoms in Children [NCT01272635]Phase 3607 participants (Actual)Interventional2011-03-31Completed
An Open-label, Randomized, Cross-over Interventional Study to Evaluate the Efficacy and Safety of Tocilizumab Versus Corticosteroids in Hospitalised COVID-19 Patients With High Risk of Progression [NCT04345445]Phase 3310 participants (Anticipated)Interventional2020-04-15Not yet recruiting
Phase II Randomized Double Blind Trial of Methylprednisolone and N-acetylcysteine in Hepatic Resections. [NCT01726465]Phase 250 participants (Actual)Interventional2012-11-30Terminated(stopped due to The first phase was completed)
Efficacy and Safety Evaluation of Rapamycin Combined With Methylprednisolone in the Treatment of Hyperthyroidism Exophthalmos: A Randomized, Controlled, Multicenter Clinical Trial. [NCT05532072]Early Phase 1140 participants (Anticipated)Interventional2022-09-30Not yet recruiting
Intraorbital Injection Versus Oral Steroid in Patients With Anterior Idiopathic Orbital Inflammation: A Randomized Clinical Trial [NCT03958344]Phase 3120 participants (Anticipated)Interventional2022-01-01Recruiting
Extended Follow-up of a Randomized Placebo-controlled Trial of Local Steroid Injection in Carpal Tunnel Syndrome [NCT02652390]Phase 4111 participants (Actual)Interventional2016-02-29Completed
Perks of Methylprednisolone for Hospitalized COVID-19 Patients: A Clinical Trial [NCT04559113]200 participants (Anticipated)Interventional2020-05-01Recruiting
Maternal Epidural Steroids to Prevent Neonatal Exposure to Hyperthermia and Inflammation [NCT02212210]Early Phase 1135 participants (Actual)Interventional2012-02-29Terminated(stopped due to PI permanently closed accrual for the study based on FDA warning issued in April 2014. Study is closed)
The Use of Intra-articular Corticosteroid Injection to Treat Osteoarthritis of the Carpometacarpal Joint: A Randomized Control Trial [NCT04177433]Phase 490 participants (Anticipated)Interventional2020-12-02Recruiting
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics (Biomarkers) of BI 653048 BS H3PO4 Capsule Formulation Administered as Multiple Doses of 25 mg to 200 mg qd for 10 Days. A Randomised, Double-blind Within Dose Groups, Placebo-controlled, Multipl [NCT02217631]Phase 1140 participants (Actual)Interventional2009-10-31Completed
A Proof of Concept Study to Determine the Local Delivery and Efficacy of Intravenously Injected PEG-liposomal Prednisolone Sodium Phosphate (Nanocort) in Atherosclerotic Tissue in Subjects With Peripheral Artery Disease. [NCT01647685]Phase 1/Phase 221 participants (Anticipated)Interventional2012-05-31Recruiting
Efficacy of Moxifloxacin 0.5%/Prednisolone 1% Fixed Combination Compared With Individual Administration of Moxifloxacin 0.5% and Prednisolone 1% in the Prevention of Post Operative Inflammation in Patients Having Lasik Surgery [NCT01603030]Phase 366 participants (Anticipated)Interventional2012-06-30Not yet recruiting
Preemptive Effect of Dexamethasone and Methylprednisolone on Pain, Swelling and Trismus After Third Molar Surgery: a Split-mouth Randomized Triple-blind Clinical Trial [NCT01603498]18 participants (Actual)Interventional2011-04-30Completed
A Multicentre, Randomised, Double Blind, Double Dummy, Active Comparator Controlled, Parallel Group Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis [NCT00299013]Phase 3796 participants (Actual)Interventional2006-03-31Completed
Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years Comparison of Two Strategies Combining Steroids With or Without Immunosuppressants [NCT00307671]Phase 4108 participants (Actual)Interventional2005-07-31Completed
A Randomized, Controlled, Parallel-Group, Multicenter Study of Extracorporeal Photoimmune Therapy With THERAKOS* UVADEX* for the Treatment of Patients With Newly Diagnosed Acute Graft Versus-Host Disease [NCT00282503]Phase 319 participants (Actual)Interventional2006-01-31Terminated(stopped due to Lack of recruitment)
Long Term Tapering or Standard Steroids for Nephrotic Syndrome [NCT00308321]Phase 450 participants (Anticipated)Interventional2003-09-30Recruiting
Multicenter, Open-label, Randomized Study on Steroid-free Immunosuppression, in Comparison With Daily Steroid Therapy, in Children With Stable Renal Transplant Function Under Cyclosporine (CyA) and Mycophenolate Mofetil (MMF) [NCT00309218]Phase 342 participants (Actual)Interventional1999-03-31Completed
Comparison of Efficacy of Intra-articular Morphine vs Methylprednisolone in Patients With Knee Osteoarthritis. A Single - Blind, Randomized-controlled Study [NCT06163755]Phase 20 participants (Actual)Interventional2018-01-01Withdrawn(stopped due to Lack of funding)
A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination With Anticancer Agents in Patients With Advanced/Metastatic Solid Tumours [NCT05489211]Phase 2670 participants (Anticipated)Interventional2022-09-06Recruiting
Epidural Steroid Following Discectomy for Herniated Lumbar Disc Reduces Neurological Impairment and Enhances Recovery. A Randomized Study With Two-year Follow-up [NCT01499641]200 participants (Actual)Interventional2001-05-31Completed
A Prospective, Multi-Center, Randomized, Double-Masked, Positive-Controlled Phase 3 Clinical Trial Designed to Evaluate the Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution Compared to Prednisolone Acetate Ophthalmic Suspen [NCT01505088]Phase 3193 participants (Actual)Interventional2011-12-31Completed
The Efficacy of Exercise Therapy Followed by Ultrasound Guided Injection in Patients With a Painful Shoulder - a Randomised Controlled Study With Blinded Observer [NCT01506804]99 participants (Actual)Interventional2010-11-30Completed
[NCT01627236]120 participants (Anticipated)Interventional2012-12-31Recruiting
Evaluation of Efficacy and Hypothalamus-pituitary-adrenal Axis Suppression Due to a Single Intrabursal Injection of Corticosteroids in Patients With Shoulder Calcific Tendinopathy [NCT01652495]Phase 444 participants (Actual)Interventional2012-03-31Completed
Effect of Different Therapeutic Strategies on Regulatory T Cells in Kidney Transplantation: a Randomized Study [NCT01640743]58 participants (Actual)Interventional2010-03-31Completed
Randomized, Multicentric Study Evaluating the Efficacy and the Safety of Methylprednisolone Bolus in the Treatment of Renal Sarcoidosis [NCT01652417]40 participants (Actual)Interventional2012-10-31Terminated(stopped due to insufficient recruitment)
The Effect of Different Intra-articular Injections on Pain and Function in Primary Gonarthrosis [NCT05291793]80 participants (Actual)Interventional2020-04-01Completed
A Multicenter, Open-Label Study to Estimate the Effect Sizes of HRCT Endpoints in Response to GLUCOCORTICOID Induction Therapy in Subjects With Pulmonary Sarcoidosis [NCT03324503]8 participants (Actual)Interventional2017-12-08Completed
Assessment of the Efficacy of an Intradiscal Injection of Corticoids in Modic I Discopathies. [NCT01694134]Phase 350 participants (Actual)Interventional2012-07-12Completed
Alternative Treatment Paradigm for Natalizumab Trial [NCT01710228]Phase 20 participants (Actual)Interventional2013-07-31Withdrawn(stopped due to sponsor stopped)
Determining Optimal Dose of Corticosteroids in COPD Exacerbations: A Pilot Study [NCT01742338]Phase 4125 participants (Anticipated)Interventional2012-05-03Suspended(stopped due to The study has been suspended to address research staffing and the feasibility of continued recruitment)
Effect of Steroids on Cerebrospinal Fluid Markers of Inflammation and Neuronal Damage After Surgical Aortic Valve Replacement [NCT01755338]30 participants (Actual)Interventional2012-12-31Completed
Phase II, Randomized, Placebo-Controlled, Double-Blind Clinical Trial to Evaluate the Effects and Safety of Infusion of Low-Doses of Methylprednisolone in Early ALI and ARDS in Children [NCT01757899]Phase 20 participants (Actual)Interventional2014-01-31Withdrawn(stopped due to Technical problems)
A Randomised, Single Blind, Placebo-Controlled, Cross-over, Phase 1 Methodology Study to Validate the Cantharidin Blister Model in Healthy Male Volunteers [NCT01762787]Phase 140 participants (Actual)Interventional2010-08-17Completed
Phase 3 Open Label Randomised Multicentre Controlled Trial of Rituxmab and Mycophenolate Mofetil Without Oral Steroids for the Treatment of Lupus Nephritis [NCT01773616]Phase 324 participants (Actual)Interventional2015-04-30Terminated(stopped due to Study assessments for patients recruited continuing per protocol so patients receive a minimum of 6 months follow up. No safety concerns have been raised.)
FDG PET/CT: Reducing False Positive Mediastinal Uptake by Premedicating With Methylprednisolone [NCT01789892]0 participants (Actual)Interventional2011-06-30Withdrawn(stopped due to no patient accrual)
Safety and Efficacy of Nonsteroidal Antiinflammatory Drug and Glucocorticoids in Acute Sciatica [NCT01816334]Phase 450 participants (Actual)Interventional2013-01-31Completed
Addition of Pyridoxine to Prednisolone in the Treatment of Infantile Spasms: A Randomized Controlled Trial [NCT01828437]Phase 362 participants (Actual)Interventional2012-11-30Completed
A Multi-center Randomized Controlled Trial of Efficacy and Safety of Perineural Local Anesthetics and Steroids for Chronic Peripheral Post-traumatic Neuropathic Pain: The Resperist Study [NCT03009500]Phase 33 participants (Actual)Interventional2017-01-31Completed
Study of Visual Recovery After Erythropoietin (EPO) Injection, in Patients With Traumatic Optic Neuropathy (TON) [NCT01783847]Phase 1/Phase 2117 participants (Actual)Interventional2015-02-28Completed
Double-blind Randomized Controlled Trial of Anakinra, Pentoxifylline, and Zinc Compared to Methylprednisolone in Severe Acute Alcoholic Hepatitis [NCT01809132]Phase 2/Phase 3104 participants (Actual)Interventional2013-09-30Completed
SMART Trial: Steroid Dosing by bioMARker Guided Titration in Critically Ill Patients With Pneumonia [NCT03852537]Phase 244 participants (Actual)Interventional2019-12-02Completed
Killer Immunoglobulin-like Receptor (KIR) Incompatible Unrelated Donor Hematopoietic Cell Transplantation (SCT) for AML With Monosomy 7, -5/5q-, High FLT3-ITD AR, or Refractory and Relapsed Acute Myelogenous Leukemia (AML) in Children: A Children's Oncolo [NCT00553202]Phase 2158 participants (Actual)Interventional2008-01-31Completed
Towards a Self-Administered Hearing Protection Regimen [NCT04826237]Phase 4100 participants (Anticipated)Interventional2023-02-09Recruiting
Efficacy of Injectable Methylprednisolone Sodium Succinate in the Treatment of Patients With Signs of Severe Acute Respiratory Syndrome Under the New Coronavirus (SARS-CoV2): a Phase IIb, Randomized, Double-blind, Placebo-controlled, Clinical Trial. [NCT04343729]Phase 2416 participants (Actual)Interventional2020-04-18Completed
Randomised Evaluation of COVID-19 Therapy (RECOVERY) in Children With PIMS-TS in Switzerland (SWISSPED-RECOVERY) [NCT04826588]Phase 376 participants (Actual)Interventional2021-05-23Completed
A Randomized, Controlled, Open-Label Study to Evaluate the Efficacy of Extracorporeal Photopheresis (ECP) Versus Corticosteroids in the Treatment of Patients With Secondary Progressive Multiple Sclerosis (SPMS) [NCT02296346]13 participants (Actual)Interventional2014-10-31Terminated(stopped due to Low enrollment/PI relocated. New site couldn't reach agreement with manufacturer)
A Post Marketing Surveillance to Evaluate the Safety and Efficacy of Lotemax Ophthalmic Suspension 0.5% [NCT01437982]Phase 4140 participants (Anticipated)Interventional2010-08-05Completed
Efficacy of Peripheral Nerve Blocks for Episodic Migraine Treatment and Prophylaxis [NCT05734625]Phase 260 participants (Anticipated)Interventional2023-07-10Recruiting
Focal Cerebral Arteriopathy Steroid Trial [NCT06040255]Phase 480 participants (Anticipated)Interventional2023-10-01Not yet recruiting
Single Blind Randomized Controlled Trial to Assess the Safety and Efficacy of High Dose Pulse Intravenous Corticosteroid Therapy to Treat Patients With Complicated/Fulminant Acute Myocarditis [NCT05150704]Phase 3288 participants (Anticipated)Interventional2021-10-07Recruiting
Glucocorticoid Treatment in Patients Undergoing TAVR to Reduce the Incidence of Atrioventricular Block and Pacemaker Implantation [NCT06076824]Phase 4100 participants (Anticipated)Interventional2023-08-12Recruiting
Systemic Corticosteroids in Treatment of Post-COVID-19 Interstitial Lung Disease [NCT04988282]Phase 4262 participants (Actual)Interventional2021-05-24Completed
Early Short Course Corticosteroids in Hospitalized Patients With COVID-19 [NCT04374071]250 participants (Actual)Observational2020-03-12Completed
Medrol® In Contact Dermatitis: A Prospective Study To Assess The Safety And Effectiveness Of Medrol In Contact Dermatitis In Indian Subjects [NCT00929981]80 participants (Actual)Observational2009-09-30Completed
A Randomized Controlled Trial of Rituximab Versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous Nephropathy [NCT03018535]Phase 376 participants (Actual)Interventional2012-01-31Active, not recruiting
The Effect of 4.5 Gram Methylprednisolone Administered Once Weekly for 12 Weeks on Bone Metabolism in Graves´ Ophthalmopathy [NCT03122847]30 participants (Anticipated)Observational2017-06-07Active, not recruiting
Phase 2/Phase 3 of the Randomized Control Trial to Evaluate the Efficacy of Autologous Blood Injection Versus Local Corticosteroid Injection for Treatment of Lateral Epicondylitis. [NCT00947765]Phase 2/Phase 360 participants (Actual)Interventional2007-01-31Completed
Autologous Hematopoietic Stem Cell Transplant for Patients With Systemic Sclerosis and Cardiac Dysfunction [NCT03593902]Phase 2/Phase 39 participants (Actual)Interventional2018-05-17Terminated(stopped due to PI Sabbatical)
Clinical Evaluation of New Treatment Strategy of Mucous Membrane Pemphigoid Using Large Dose of Prednisolone Plus Intra-lesional of Triamcinolone Acetonide Followed by Combination of Mycophenolate Mofetil, Dapsone and Low Dose Prednisolone [NCT04744623]Phase 2/Phase 310 participants (Actual)Interventional2020-09-30Active, not recruiting
Prolonged Low Doses of Methylprednisolone for Patients With COVID-19 Severe Acute Respiratory Syndrome [NCT04323592]173 participants (Actual)Observational [Patient Registry]2020-03-23Completed
Clinical Effectiveness of Symptomatic Therapy Compared to Standard Step up Care for the Treatment of Low Impact Psoriatic Oligoarthritis: a 2 Arm Parallel Group Feasibility Study [NCT03797872]Phase 41 participants (Actual)Interventional2019-04-17Completed
Effect of Preoperative Intravenous High Dose Methylprednisolone on Endothelial Function in Patients Scheduled for Total Knee-arthroplasty [NCT02332629]Phase 370 participants (Actual)Interventional2015-01-31Completed
Effect of Preoperative Intravenous High Dose Methylprednisolone on Quadriceps Muscle Function in Patients Scheduled for Total Knee-arthroplasty [NCT02319343]Phase 370 participants (Actual)Interventional2015-01-31Completed
Multicenter, Randomized, Observer-blind, Controlled Study of the Anti-IL-6 Receptor Antibody Tocilizumab (TCZ) or Methylprednisolone (MP) Treatment in Patients With Active Moderate-severe Graves' Orbitopathy [NCT04876534]Phase 264 participants (Anticipated)Interventional2019-12-18Recruiting
A National Prospective Study of Patients With Hepatitis Induced by Immune Checkpoint Inhibitors; Characterization of Liver Injury, Outcome of Therapy and Randomization to Either Prednisolone or Mycophenolate Mofetil Treatment in Case of Relapse [NCT04810156]Phase 260 participants (Anticipated)Interventional2021-04-07Recruiting
Phase 2 Historically Controlled Trial of Corticosteroids in Young Boys With Duchenne Muscular Dystrophy [NCT02167217]Phase 225 participants (Actual)Interventional2014-04-17Completed
Pilot Study in AIDS-Related Lymphomas [NCT00002524]Phase 246 participants (Actual)Interventional1993-06-30Completed
A Prospective Randomized Double-blinded Controlled Single Center Clinical Study of the Efficacy and Safety for Tofacitinib Compared With Glucocorticoid in the Remission-reduction Treatment of Active Takayasu's Arteritis [NCT05749666]Phase 350 participants (Anticipated)Interventional2023-01-20Recruiting
Treatment of Metastatic Prostate Cancer That is Hormone-Independent: Evaluation of the Role of Chemotherapy on the Quality of Life of Patients. Phase II Study [NCT00003682]Phase 3160 participants (Anticipated)Interventional1998-10-31Terminated(stopped due to lack of inclusions)
Sudden Hearing Loss Multicenter Treatment Trial [NCT00097448]Phase 3255 participants (Actual)Interventional2004-12-31Completed
Phase II Trial of Natalizumab (Tysabri®) Plus Prednisone for Initial Therapy of Acute Graft Versus Host Disease (aGVHD) of the Gastrointestinal Tract [NCT02176031]Phase 221 participants (Actual)Interventional2015-01-31Completed
STeroids to REduce Systemic Inflammation After Infant Heart Surgery (STRESS) [NCT03229538]Phase 31,263 participants (Actual)Interventional2017-10-18Completed
A Randomised, Comparator Controlled, Two Part, Open-label Study to Evaluate the Safety, Tolerability and Pharmacodynamics of Multiple Doses of Otelixizumab in Patients With Thyroid Orbitopathy [NCT01114503]Phase 22 participants (Actual)Interventional2010-07-07Terminated(stopped due to Clinical study in Graves' ophthalmopathy terminated until there is a better understanding of an efficacious dose with Otelixizumab from other clinical studies.)
Single Center, Randomized, Double-Blind, Placebo-Controlled Treatment Of Knee Osteoarthritis With Intra-Articular Infliximab [NCT01144143]Phase 416 participants (Actual)Interventional2007-07-31Completed
Comparison of the Efficacy of Two Different Glucocorticoid Regimens for Treatment of Active Moderate-to-severe Graves' Orbitopathy [NCT05793359]62 participants (Actual)Observational [Patient Registry]2017-07-25Completed
Efficacy and Safety of Corticosteroids in COVID-19: A Prospective Randomized Controlled Trails [NCT04273321]86 participants (Actual)Interventional2020-02-14Completed
Retrobulbar Methylprednisolone as Adjunctive Treatment in Optic Neuritis. Randomized Controlled Trial. [NCT04942002]Phase 2/Phase 350 participants (Anticipated)Interventional2021-06-15Recruiting
Safety and Efficacy of Topical Loteprednol Etabonate 0.5%, Versus Prednisolone Acetate 1%, for the Treatment of Intraocular Inflammation Following Surgery for Childhood Cataract [NCT01475643]Phase 3107 participants (Actual)Interventional2013-06-30Completed
Hyper-CVAD With Liposomal Vincristine (Hyper-CMAD) in Acute Lymphoblastic Leukemia [NCT01319981]Phase 231 participants (Actual)Interventional2013-03-05Completed
Evaluation of DEXTENZA on the Management of Pain and Inflammation in Patients With Anterior Uveitis Compared to Standard of Care Topical Corticosteroids [NCT04426734]Phase 430 participants (Anticipated)Interventional2020-07-01Not yet recruiting
Corticosteriods vs. Saline vs. Air Placebo Intra-articular Injections for Knee Osteoarthritis: A Single Blinded Prospective Randomized Trial [NCT02995083]Early Phase 10 participants (Actual)Interventional2017-06-30Withdrawn(stopped due to Study deemed not feasible)
Randomized Controlled Trial Comparing Low Dose and High Dose Steroids in Patients Undergoing Colorectal Surgery [NCT01559675]121 participants (Actual)Interventional2010-09-30Completed
Dextenza vs Prednisolone Acetate After Cataract Surgery for Patients With Diabetes [NCT04977427]Phase 4200 participants (Anticipated)Interventional2021-07-31Not yet recruiting
A Pilot Study Investigating the Feasibility and Efficacy of Locoregional Intra-arterial Administration of Methylprednisolone as a Bridge Therapy to Treat Symptomatic Flares in Inflammatory Bowel Disease. [NCT05587673]Phase 130 participants (Anticipated)Interventional2022-10-06Recruiting
Comparison of Efficacy and Safety of Two Different Ultrasound-Guided Suprascapular Nerve Block Techniques in Chronic Shoulder Pain: A Prospective Double-Blinded Randomized Controlled Study [NCT04938037]80 participants (Anticipated)Interventional2021-06-01Recruiting
A Feasibility Randomised Placebo-controlled Trial With Objective Outcome Measures to Evaluate the Efficacy of Biosimilar Rituximab in Musculoskeletal and Mucocutaneous Systemic Lupus Erythematosus [NCT03054259]Phase 230 participants (Anticipated)Interventional2017-09-21Recruiting
Transverse Abdominis Plane Block Using Liposomal Bupivacaine for Post-operative Cesarean Delivery Analgesia- Walking Towards Recovery [NCT04393207]Phase 4300 participants (Anticipated)Interventional2022-02-01Recruiting
Intracanalicular Dexamethasone Insert for Management of Post-operative Pain and Inflammation in Patients Undergoing Vitreoretinal Surgery [NCT04371445]Phase 430 participants (Anticipated)Interventional2020-12-01Enrolling by invitation
Evaluation of Sleep EEG Changes in Paediatric Patients With Language Dysfunction: A Follow up Study. Evaluation of Sleep EEG Changes in Paediatric Patients With Language Dysfunction: A Follow up Study. Evaluation of Sleep EEG Changes in Pediatric Patients [NCT05487521]Phase 393 participants (Actual)Interventional2020-02-20Completed
Clinical Study of the Effect of Methylprednisolone Combined With Two Hydroxypropyl Theophylline on Respiratory Dynamics During Thoracoscopic Lobectomy [NCT04810819]110 participants (Anticipated)Interventional2021-07-01Not yet recruiting
The Effectiveness of Pulsed Radiofrequency of the Suprascapular Nerve and Shoulder Joint Compared to Intra-articular Corticosteroid Injection for Hemiplegic Shoulder Pain Management and Functional Improvement. [NCT05563571]20 participants (Anticipated)Interventional2022-04-01Recruiting
DEXTENZA VS. PREDNISOLONE ACETATE 1% in the Incidence of Pseudophakic Macular Edema in Patients With Diabetic Retinopathy Undergoing Cataract Surgery [NCT04362241]Phase 430 participants (Anticipated)Interventional2020-08-07Recruiting
The Effect of Intravenous Glucocorticoids on the Tearfilm in Eyes With Thyroid-associated Ophthalmopathy [NCT01579539]Phase 318 participants (Actual)Interventional2013-06-27Completed
Pre-operative Intravenous Steroid in Unilateral Primary Total Knee Replacement for Pain Relief and Recovery: A Double-Blind Randomized Controlled Trial [NCT03082092]Phase 460 participants (Actual)Interventional2017-06-01Completed
Autologous Hematopoietic Stem Cell Transplant for Neuromyelitis Optica Spectrum Disorder (NMOSD) [NCT03829566]Phase 2/Phase 30 participants (Actual)Interventional2019-11-30Withdrawn(stopped due to Discontinued by Investigator)
Adhesive Capsulitis: Prospective Analysis of Efficacy and Financial Impact for Use of Physical Therapy in Treatment [NCT02283996]Phase 4260 participants (Anticipated)Interventional2014-11-30Recruiting
Efficacy and Safety of MEthylprednisolone Administered Intravenously for the Treatment of Patients With Active AnkyLosing spondyLitis (METALL) - a 12-week, Prospective, Open-label, Pilot Study [NCT01790022]Phase 220 participants (Actual)Interventional2012-07-31Active, not recruiting
Randomized, Double-Masked, Vehicle Controlled, Clinical Evaluation To Assess The Safety And Efficacy Of Nepafenac Ophthalmic Suspension, 0.3% For Improvement In Clinical Outcomes Among Diabetic Subjects Following Cataract Surgery [NCT01872611]Phase 3819 participants (Actual)Interventional2013-06-30Completed
Intradiscal Gelified Ethanol Versus Intradiscal Steroid in Refractory Lumbar Discogenic Pain: a Randomized Single-blind Study [NCT03415828]83 participants (Actual)Interventional2018-05-29Active, not recruiting
Phase II Study of Ofatumumab in Combination With High Dose Methylprednisolone Followed by Ofatumumab and Lenalidomide Consolidative Therapy for the Treatment of Relapsed or Refractory CLL/SLL The HiLOG Trial [NCT01497496]Phase 229 participants (Actual)Interventional2012-01-26Completed
Dextenza in Pterygium Surgery [NCT04403516]Phase 430 participants (Actual)Interventional2020-10-01Completed
Comparison of Dropless Prophylaxis After Routine Phacoemulsification to Standard Drops Regimen [NCT02515045]Phase 459 participants (Actual)Interventional2015-01-31Completed
Prospective, Randomized Clinical Trial of Meibomian Gland Probing Versus Sham Procedure for Refractory Meibomian Gland Dysfunction [NCT02256969]Phase 445 participants (Actual)Interventional2014-10-31Completed
Use of G-CSF Stimulated HLA-Identical Allogeneic Peripheral Blood Stem Cells for Patients With High Risk Acute Myelogenous Leukemia or CML in Blast Crisis [NCT00002833]Phase 253 participants (Actual)Interventional1994-10-31Completed
Safety and Effectiveness of Single-dose Subconjunctival Triamcinolone Compared to Topical Prednisolone Eye Drops in Manual Small Incision Cataract Surgery [NCT05248139]100 participants (Anticipated)Interventional2022-10-31Not yet recruiting
Phase II Study of Prednisolone/Methylprednisolone Absorption in Children With Juvenile Dermatomyositis [NCT00004357]Phase 26 participants (Actual)Interventional1997-09-30Completed
Phase III Randomized, Double-Blind Study of Methylprednisolone by 24- Versus 48-Hour Infusion Versus Tirilazad for Acute Spinal Cord Injury [NCT00004759]Phase 3497 participants Interventional1991-12-31Completed
An Open-label Study to Evaluate the Effect of MabThera in Combination With Methotrexate on Disease Activity in Patients With Active Rheumatoid Arthritis After DMARD Treatment Failure [NCT02006706]Phase 315 participants (Actual)Interventional2006-08-10Completed
Intra-articular and Intravenous Infliximab in the Treatment of Resistant Seronegative Oligoarthritis of the Knee [NCT01216631]Phase 21 participants (Actual)Interventional2010-09-30Terminated(stopped due to Unable to recruit)
Effects of a Multiple Sclerosis Relapse Therapy With Methylprednisolone (MP) During Pregnancy on Offspring Cognitive Function, Stress Sensitivity, Behaviour and Functional and Structural Brain Development [NCT04832269]80 participants (Anticipated)Observational2020-10-19Recruiting
De Novo Everolimus Versus Tacrolimus in Combination With Mofetil Mycophenolate and Low Dose Corticosteroids to Reduce Tacrolimus Induced Nephrotoxicity in Liver Transplantation: a Prospective, Multicentric, Randomised Study [NCT02909335]Phase 30 participants (Actual)Interventional2016-11-30Withdrawn
[NCT02115997]Phase 430 participants (Actual)Interventional2015-07-06Completed
Does Anesthetic Contribute to Symptomatic Relief in Corticosteroid Injections for Knee Osteoarthritis? A Double-Blind Randomized Trial Comparing Corticosteroid/Ropivacaine Versus Corticosteroid/Saline Injections [NCT02576249]Phase 429 participants (Actual)Interventional2015-10-31Completed
A Multicenter, Randomized, Open-label, Blinded-assessor, Follow-up, Phase 4 Study in Patients With Rheumatoid Arthritis Who Have Completed the Initial Treatment Part in the NORD-STAR Study and Have Reached Stable Low Disease Activity [NCT02466581]Phase 425 participants (Actual)Interventional2015-02-03Active, not recruiting
Preoperative Methylprednisolone on Thoracic Endovascular Repair for Reducing Post-implantation Syndrome [NCT05349071]158 participants (Anticipated)Interventional2022-05-01Not yet recruiting
Safety and Efficacy of Topical Tacrolimus 0.05% in the Treatment of Ocular Graft-Versus-Host Disease [NCT01977781]Phase 140 participants (Actual)Interventional2013-12-31Completed
Efficacy and Safety of Steroid for Treatment of Acute/Subacute Severe Cerebral Venous Thrombosis. [NCT05990894]248 participants (Actual)Observational2018-01-01Completed
High Dose Steroids for Liver Resection - Effect on Complications and Endothelial Function in the Immediate Postoperative Phase - a Randomized, Doubleblind, Controlled Trial [NCT03403517]Phase 4174 participants (Actual)Interventional2017-12-11Completed
Safety and Efficacy of KPI-121 1% Ophthalmic Suspension Versus Prednisolone Acetate Ophthalmic Suspension 1% for the Treatment of Inflammation Following Cataract Surgery in Children 0 to 3 Years of Age [NCT03596723]Phase 32 participants (Actual)Interventional2018-07-03Terminated(stopped due to NDA #210565 did not trigger the need for a Pediatric Research Equity Act study.)
A Randomized Prospective Study of Early Intensification Versus Alternating Triple Therapy for Patients With Poor Prognosis Lymphoma [NCT00002835]Phase 3116 participants (Actual)Interventional1995-10-30Completed
[NCT00004785]Phase 354 participants Interventional1995-11-30Completed
Phase I/II Study of Idarubicin, Cytarabine, and Nivolumab in Patients With High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) [NCT02464657]Phase 1/Phase 244 participants (Actual)Interventional2015-07-31Completed
Open Randomized Single Centre Clinical Trial to Evaluate Methylprednisolone Pulses and Tacrolimus in Patients With Severe Lung Injury Secondary to COVID-19 [NCT04341038]Phase 384 participants (Anticipated)Interventional2020-04-01Recruiting
Physiologic Effects of Stress Dose Corticosteroids in the Management of Inhospital Cardiac Arrest - CORTICA [NCT02790788]Phase 1/Phase 2100 participants (Actual)Interventional2016-11-04Completed
Efficacy and Safety of Loteprednol 0.5% Gel for Routine Prophylaxis After Photorefractive Keratectomy Compared to Prednisolone Acetate 1% Suspension and Fluorometholone 0.1% Suspension [NCT03123614]Phase 4131 participants (Actual)Interventional2014-09-19Completed
A Phase 4, Randomized, Double-Masked, Single Center, Placebo-Controlled Adaptive Clinical Trial, Using Prednisolone Sodium Phosphate Ophthalmic Solution, 1%, in Subjects With Allergic Conjunctivitis to Evaluate a Modified Conjunctival Allergen Challenge ( [NCT01534195]Phase 411 participants (Actual)Interventional2012-01-31Completed
Treatment of COVID-19 Pneumonia With Glucocorticoids. A Randomized Controlled Trial [NCT04438980]Phase 372 participants (Actual)Interventional2020-05-15Completed
Combined Radiotherapy and Intravenous Steroids for Early Progressive Thyroid Eye Disease [NCT02339142]Phase 4100 participants (Anticipated)Interventional2015-01-31Not yet recruiting
Targeting Iatrogenic Cushing's Syndrome With 11β-hydroxysteroid Dehydrogenase Type 1 Inhibition (TICSI) [NCT03111810]Phase 232 participants (Actual)Interventional2017-05-25Completed
Intra-articular Injections of Platelet-rich Plasma, Hyaluronic Acid, or Corticosteroids for Knee Osteoarthritis, Which is Better? A Prospective Study of a Single-blind Randomized Control Trial RCT From the Iraqi Population [NCT04980105]Phase 3150 participants (Actual)Interventional2020-03-02Active, not recruiting
Hit Hard and Early. The Effect of High Dose Methylprednisolone on Nailfold Capillary Changes and Biomarkers in Early SSc: a 12-week Randomised Explorative Double-blind Placebo-controlled Trial. [NCT03059979]Early Phase 130 participants (Anticipated)Interventional2017-01-31Recruiting
Second Affiliated Hospital, College of Medicine, Zhejiang University [NCT04918953]Phase 290 participants (Anticipated)Interventional2021-06-02Not yet recruiting
The Efficacy and Safety of R-EPOCH and R-CHOP Regimen for Patients With AIDS Associated CD20+ Diffuse Large B Lymphoma [NCT03045471]50 participants (Anticipated)Observational2017-03-01Not yet recruiting
Study of the Excretion of Orally Administered Corticosteroids for the Improval of the Detection of Said Substances in Anti-doping Controls [NCT04791345]Phase 150 participants (Anticipated)Interventional2021-02-26Recruiting
Autologous Platelet Rich Fibrin Versus Steroid in Ultrasound-Guided Sacroiliac Joint Injection for Joint Dysfunction (Randomized Comparative Study) [NCT04757740]Phase 494 participants (Anticipated)Interventional2021-03-01Recruiting
The Role of Doxycycline in Management of Moderate to Severe Chronic Rhinosinusitis With Nasal Polyps [NCT02569437]Phase 249 participants (Actual)Interventional2014-09-30Terminated(stopped due to A high percentage of patients were dropping out of the study and were not able to complete the protocol.)
Topical Use of Corticosteroid to Prevent Epiretinal Membrane Formation in Eyes With Retinal Tear Undergoing Laser Retinopexy: a Pilot Prospective Clinical Study [NCT02412059]200 participants (Actual)Interventional2015-08-31Completed
Triamcinolone Versus Methylprednisolone in Ultrasound Guided Transversus Abdominis Plane Block in Major Open Abdominal Surgery [NCT04480775]Phase 2/Phase 384 participants (Actual)Interventional2020-07-15Completed
Safety and Efficacy of Steroids in the Management of Fulminant Hepatic Failure Due to Hepatitis A Virus in the Pediatric Age Group [NCT02375867]Phase 433 participants (Actual)Interventional2015-01-31Completed
Once a Month High-dose Methylprednisolone During Wash-out Period Between Natalizumab and Fingolimod Treatments in Patients With Multiple Sclerosis: a Randomised, Controlled, Double-blind Trial (NTZ2FTY) [NCT02769689]Phase 456 participants (Anticipated)Interventional2019-06-12Recruiting
Intra-Arterial Steroid Administration of De Novo Acute Graft-vs-Host Disease of the Gastrointestinal Tract: A Phase II Study [NCT02425813]Phase 20 participants (Actual)Interventional2015-10-31Withdrawn(stopped due to Slow Accrual)
Comparison of the Treatment Efficacy of High-Dose Corticosteroid and Tocilizumab During Clinical Worsening in Patients With COVID-19 Pneumonia [NCT05133635]Phase 40 participants (Actual)Interventional2021-02-01Withdrawn(stopped due to A recent study suggested a new corticosteroid regime for intensive care unit patients.)
Corticosteroids in Severe Alcoholic Hepatitis Patients With Early Spontaneous Improvement [NCT03160651]140 participants (Anticipated)Interventional2018-02-09Recruiting
Comparison Between Ultrasound Guided Ozone, Platelet-Rich Plasma or Steroid Injection in the Treatment of Sacroiliitis; a Randomized Double Blinded Controlled Study [NCT05914350]105 participants (Anticipated)Interventional2023-06-23Recruiting
Investigating Differences in Flare Reaction Incidence and Intensity Following Trigger Finger Injections Using Betamethasone and Methylprednisolone [NCT04900220]Phase 466 participants (Actual)Interventional2021-09-15Completed
Genomic Response of Human Immune and Non-Immune Cells to Glucocorticoids [NCT02798523]Phase 133 participants (Actual)Interventional2017-01-24Completed
Steroid Versus Platelet Rich Plasma in Ultrasound Guided Sacroiliac Joint Injection for Chronic Low Back Pain [NCT02334475]40 participants (Actual)Interventional2013-07-31Completed
Effect of Preoperative Intravenous High Dose Methylprednisolone on Glucose Homeostasis in Patients Scheduled for Total Hip- and Knee-arthroplasty [NCT02332603]Phase 3134 participants (Actual)Interventional2015-01-31Completed
Randomized, Unicentric, Open, Controlled Clinical Trial, in Phase Iii, to Demonstrate the Effectiveness of Tocilizumab Against Systemic Corticotherapy in Patients Admitted by Covid-19 With Bilateral Pneumonia and Poor Evolution [NCT05002517]Phase 360 participants (Anticipated)Interventional2020-09-03Active, not recruiting
Antiviral Treatment in Facial Palsy. Randomized Control Trial [NCT02328079]50 participants (Actual)Interventional2013-04-30Completed
Comparison Of Two Corticosteroid Dosing Regimens For Prevention Of Corneal Transplant Rejection Episodes After Descemet's Membrane Endothelial Keratoplasty [NCT01448213]Phase 2264 participants (Actual)Interventional2011-10-31Completed
A Phase II Randomized, Double-Blind, Placebo-Controlled Trial of Intravenous Methylprednisolone as a Treatment for Presumed Hantavirus Cardiopulmonary Syndrome [NCT00128180]Phase 266 participants (Actual)Interventional2003-01-31Completed
A Phase II Study of Rituximab and Temozolomide in Recurrent Primary CNS Lymphoma [NCT00248534]Phase 216 participants (Actual)Interventional2005-09-30Terminated(stopped due to slow accrual/lack of resources/low priority due to combining 2 consortia)
A Phase 1/2 Trial Evaluating Treatment of Emergent Graft Versus Host Disease (GvHD) With AP1903 After Planned Donor Infusions (DLIs) of T-cells Genetically Modified With the iCasp9 Suicide Gene in Patients With Hematologic Malignancies [NCT01875237]Phase 1/Phase 23 participants (Actual)Interventional2013-12-27Terminated
Prospective, Randomized Comparison of Corticosteroid Dosing Regimens Following Endothelial Keratoplasty [NCT01853696]Phase 4167 participants (Actual)Interventional2013-03-31Completed
Randomized, Double-Masked, Vehicle Controlled, Clinical Evaluation To Assess The Safety And Efficacy Of Nepafenac Ophthalmic Suspension, 0.3% For Improvement In Clinical Outcomes Among Diabetic Subjects Following Cataract Surgery [NCT01853072]Phase 3881 participants (Actual)Interventional2013-06-30Completed
Blood Pressure Profile and NT-proBNP Dynamics in Response to Intravenous Methylprednisolone Pulse Therapy of Severe Graves' Orbitopathy [NCT03590080]32 participants (Actual)Observational2011-01-01Completed
Impact of Preoperative Single Corticosteroid Flash on Morbidity After Colorectal Resection: Monocentric Prospective Pilot Study [NCT03437746]Phase 278 participants (Actual)Interventional2018-03-01Terminated(stopped due to insufficient rate of inclusion)
Effect of Depo-Medrol Application on the Psoas Muscle After Transpsoas LLIF on Post-operative Hip Flexor Weakness, Thigh Pain and Numbness [NCT05929755]Phase 480 participants (Anticipated)Interventional2023-05-12Recruiting
Effect of Methylprednisolone on Systemic Inflammatory Response and Clinical Parameters During Pediatric Congenital Open-Heart Surgery: A Randomized Controlled Trial [NCT05927233]Phase 460 participants (Anticipated)Interventional2023-04-01Recruiting
The D3 Study: Drug Delivery vs Drops - A Prospective Clinical Study Evaluating Dexycu vs Prednisolone Acetate 1% in Controlling Post-operative Pain and Inflammation in Patients Undergoing Sequential Cataract Surgery [NCT04273282]Phase 431 participants (Actual)Interventional2019-12-16Completed
The Effectiveness of Enough Steroids as Inducement Therapy in Minimal Change Disease-like IgA Nephropathy [NCT01451710]30 participants (Actual)Interventional2011-03-31Completed
Double-Blind, Randomized, Parallel Group, Multicenter Study of Durolane Compared to Methylprednisolone in Subjects With Osteoarthritis of the Knee [NCT01209364]Phase 3442 participants (Actual)Interventional2007-03-31Completed
High Dose Steroids in Children With Stroke and Unilateral Focal Arteriopathy: Paediatric Arteriopathy Steroid Aspirin (PASTA) Project. A Multicentre Randomized Trial. [NCT03249844]Phase 30 participants (Actual)Interventional2022-09-01Withdrawn(stopped due to discontinuation of the trial)
Allogeneic Hematopoietic Cell Transplantation of Positively Selected CD34+ Cells and Defined Inoculum of T Cells From Related Haploidentical Donors for Older Patients With Indolent Hematologic Malignancies [NCT00185692]Phase 216 participants (Actual)Interventional2000-08-31Completed
Evaluation of a Strategy Based on the 3-month Screening Biopsy to Optimize the Immunosuppression in Renal Transplantation: the I4BiS Study [NCT02444429]Phase 3346 participants (Anticipated)Interventional2015-09-30Recruiting
Effect of Azole/Echinocandin Use on Tacrolimus Pharmacokinetics in Kidney Transplant Recipients [NCT06044558]507 participants (Actual)Observational2022-09-01Completed
[NCT00733096]Phase 2/Phase 384 participants (Actual)Interventional2008-08-31Completed
Steroids in Pediatric Acute Lung Injury/ARDS Trial: A Blinded, Placebo-controlled, Randomized Clinical Trial [NCT01274260]Phase 2100 participants (Anticipated)Interventional2010-10-31Active, not recruiting
SAAB: Randomized, Double Blind STudy of Corticosteroid Pulse After Ablation [NCT00807586]Phase 4119 participants (Actual)Interventional2008-12-31Completed
A Randomized International Phase 3 Trial of Imatinib and Chemotherapy With or Without Blinatumomab in Patients With Newly-Diagnosed Philadelphia Chromosome-Positive or Philadelphia Chromosome-Like ABL-Class B-Cell Acute Lymphoblastic Leukemia [NCT06124157]Phase 3680 participants (Anticipated)Interventional2024-01-22Not yet recruiting
A Phase 1/2 Ascending Dose Study to Evaluate the Safety and Effects on Progranulin Levels of LY3884963 in Patients With Fronto-Temporal Dementia With Progranulin Mutations (FTD-GRN) [NCT04408625]Phase 1/Phase 223 participants (Anticipated)Interventional2020-11-09Recruiting
The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis: A Pilot Study [NCT03511625]Phase 36 participants (Anticipated)Interventional2018-10-02Active, not recruiting
Phase II Study of Infliximab for the Treatment of Ipilimumab Colitis [NCT04305145]Phase 242 participants (Anticipated)Interventional2020-08-31Recruiting
High Dose Methylprednisolone Verses Low Dose in Correction of Congenital Acynotic Heart Disease [NCT05103397]Phase 475 participants (Anticipated)Interventional2021-10-16Recruiting
Patient PReference, Efficacy, and SaFety of an Intracanalicular DExamenthasone InseRt comparEd to Topical PrednisoloNe in PatienTs UndergoIng SequentiAl PhacoemuLsification With Intraocular Lens Surgery OR Combined Phacoemulsification With IOL and a Minim [NCT04563559]Phase 2/Phase 30 participants (Actual)Interventional2020-11-30Withdrawn(stopped due to PI decided not to open study)
Health Sciences University Bursa Yüksek Ihtisas Training and Research Hospital [NCT04847687]300 participants (Actual)Observational2021-03-01Completed
Randomized Controlled Trial on the Efficacy of Dexamethasone Versus Methyl Prednisolone in Covid-19 Infected Patients With High Oxygen Flow [NCT05062681]Phase 460 participants (Anticipated)Interventional2021-09-15Recruiting
Methylprednisolone and Hyaluronic Acid Versus Each Agent Alone to Control Post-extraction Complications of Impacted Mandibular Third Molar [NCT04816253]72 participants (Actual)Interventional2021-02-10Completed
[NCT03067753]Phase 228 participants (Anticipated)Interventional2016-12-31Recruiting
A Phase I/II Study of High-Dose Deoxyazacytidine, Busulfan, and Cyclophosphamide With Allogeneic Stem Cell Transplantation for Hematologic Malignancies [NCT00002831]Phase 1/Phase 224 participants (Actual)Interventional1995-08-01Completed
Effect on Pain and Inflammation With DEXTENZA Treatment in Patients Undergoing Intravitreal Anti-VEGF Injections [NCT04563299]Phase 410 participants (Actual)Interventional2020-12-09Terminated(stopped due to Subject Enrollment)
Niacin (as a Vasodilator), and a Topical Steroid (for Macular Edema), Non-Ischemic CRVO,HRVO,BRVO [NCT00493064]Phase 2/Phase 363 participants (Actual)Interventional2006-10-31Completed
A Phase II, Randomized, Clinical Trial Assessing Efficacy And Safety Of Oral Prednisolone vs Intravenous Vincristine In The Treatment Of Infantile [NCT00555464]Phase 28 participants (Actual)Interventional2007-11-30Terminated(stopped due to The introduction of oral propranolol as a highly efficacious agent for infantile hemangiomas)
Is the Effect of Systemic Steroids Treating Pollen Induced Allergic Rhinitis Mainly Due to a Placebo Effect [NCT04622917]Phase 444 participants (Actual)Interventional2019-04-10Active, not recruiting
Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass [NCT01579513]190 participants (Actual)Interventional2012-06-30Completed
A Pilot Study: Association of Beta-2 Adrenergic Agonist and Corticosteroid Injection in the Treatment of Lipomas [NCT00624416]Phase 1/Phase 210 participants (Actual)Interventional2007-10-31Completed
Single Center, Randomized, Double-Masked Evaluation of the Efficacy of PredAcetate 1% Ophthalmic Suspension Compared to Pred Acetate 0.12% Ophthalmic Suspension, Lot Etab 0.2% Ophthalmic Suspension, and Placebo in a Modified CAC Model [NCT00689078]Phase 436 participants (Actual)Interventional2008-05-31Completed
The Effect of Moderate-Dose Steroid Therapy in Sepsis: A Placebo-Controlled, Randomized Study [NCT01275638]Phase 455 participants (Actual)Interventional2005-04-30Completed
Combined T Cell Depleted Haploidentical Peripheral Blood Stem Cell and Unrelated Umbilical Cord Blood Transplantation in Patients With Hematologic Malignancies Using a Total Lymphoid Irradiation Based Preparative Regimen [NCT02199041]Phase 224 participants (Actual)Interventional2014-07-11Terminated(stopped due to The study was halted early due to slow accrual.)
A Phase II, Double-Blind, Placebo-Controlled, Multi-Center, Randomized Withdrawal Design Trial Using Adaptive Randomization Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid Arthritis [NCT01369745]Phase 2294 participants (Actual)Interventional2011-06-30Completed
Prednisolone vs. Vigabatrin in the First-line Treatment of Infantile Spasms [NCT02299115]Phase 30 participants (Actual)Interventional2017-09-05Withdrawn(stopped due to Most centres are now using oral steroids as 1st line treatment so question of efficacy is no longer of high interest.)
Effect of Drop-less Surgery Compared to Topical NSAID Alone and Combination of Steroid and NSAID on Central Macular Thickness After Cataract Surgery, a Randomized Controlled Trial [NCT03383328]Phase 4470 participants (Actual)Interventional2018-02-01Completed
Randomized Controlled Trial of Ultrasound-guided Steroid Injection Versus Wrist Splint in Patients With Carpal Tunnel Syndrome [NCT04515966]Phase 470 participants (Anticipated)Interventional2020-12-01Recruiting
Rituximab (RTX) Therapy in Steroid Resistant Patients or Patients Relapsing After Intravenous Steroids With Active TAO [NCT02378298]Phase 426 participants (Actual)Interventional2011-12-31Active, not recruiting
High Dose Steroids in Children With Stroke and Unilateral Focal Arteriopathy: A Multicentre Randomized Controlled Trial PASTA (Paediatric Arteriopathy Steroid Aspirin) Trial [NCT04873583]Phase 370 participants (Anticipated)Interventional2021-11-16Recruiting
A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy [NCT03959085]Phase 34,772 participants (Anticipated)Interventional2019-10-31Recruiting
Improvement in Function and Pain Due to Subacromial Bursitis in Relationship to Dose of Triamcinolone Acetonide and Methylyprednisolone [NCT02242630]61 participants (Actual)Interventional2014-09-30Completed
A Single-Center, Double-Masked, Randomized, Placebo-Controlled Evaluation of Prednisolone Sodium Phosphate Ophthalmic Solution, 1% Compared to Placebo in a Modified Conjunctival Allergen Challenge (CAC) Model [NCT01730872]Phase 416 participants (Actual)Interventional2012-11-30Completed
The Utility of feNO in the Differential Diagnosis of Chronic Cough: The Response to Anti-inflammatory Therapy With Prednisolone and Montelukast [NCT02479074]Phase 449 participants (Actual)Interventional2016-01-31Completed
First Line Treatment of Familiar Lymphohistiocytosis by Alemtuzumab (CAMPATH®) [NCT02472054]Phase 1/Phase 229 participants (Actual)Interventional2015-06-29Completed
Randomized Controlled Trial of Methylprednisolone Versus Dexamethasone in COVID-19 Pneumonia (MEDEAS Trial) [NCT04636671]Phase 3690 participants (Actual)Interventional2021-04-14Completed
Increased Heart Rhythm in Response to High-dose Intravenous Methylprednisolone Pulse Therapy of Moderate-to-severe Graves' Orbitopathy [NCT04391439]40 participants (Actual)Observational2011-01-01Completed
A Randomized, Open-label, Mutli-centre Study to Evaluate Patient Preference With Subcutaneous Administration of Rituximab Versus Intravenous Rituximab in Previously Untreated Patients With CD20+ Diffuse Large B-cell Lymphoma or CD20+ Follicular Non-Hodgki [NCT01724021]Phase 3743 participants (Actual)Interventional2012-12-31Completed
Zoledronic Acid or Methylprednisolone in the Management of Active Charcot's Neuroarthropathy of Foot in Patients With Diabetes Mellitus: A Randomized, Double-blind, Placebo Controlled Trial [NCT03289338]Phase 2/Phase 336 participants (Actual)Interventional2016-06-01Completed
A Phase 1 Study of Ruxolitinib, Steroids and Lenalidomide for Relapsed/Refractory Multiple Myeloma (RRMM) Patients [NCT03110822]Phase 1134 participants (Anticipated)Interventional2017-02-01Recruiting
A Phase 2 Study of Weekly 70 mg/m2 Carfilzomib for Multiple Myeloma Patients Refractory to 27 mg/m2 Carfilzomib [NCT02294357]Phase 245 participants (Anticipated)Interventional2014-12-31Terminated(stopped due to Early termination due to the difficulties to enroll subjects.)
The Effect of Positive Airway Pressure on Idiopathic Sudden Sensorineural Hearing Loss Comorbided With Obstructive Sleep Apnea: A Clinical Randomized Controlled Study [NCT04192656]Phase 4102 participants (Anticipated)Interventional2019-11-01Recruiting
Low Dose Versus High Dose Methylprednisolone for Children With Severe Mycoplasma Pneumoniae Pneumonia : a Multicenter Randomized Blinded Trial [NCT02303587]424 participants (Actual)Interventional2014-12-31Completed
Phase III Study to Evaluate the Efficacy and Safety of NPB-01 in Patients With Autoimmune Encephalitis Refractory to Steroid Pulse Therapy [NCT05177939]Phase 340 participants (Anticipated)Interventional2022-03-03Recruiting
Multicentre Prospective Open Label Clinical Study to Evaluate the Effect of Personalized Therapy on Patients With Immunoglobulin A Nephropathy. [NCT04662723]Phase 4878 participants (Anticipated)Interventional2023-05-01Recruiting
A Multi-Center, Randomized, Double-Masked Evaluation of the Efficacy of Co-Administration of FOV1101-00 (Cyclosporine 0.01% or 0.02%) and Prednisolone Acetate 0.12% (PredMild®) Compared to Prednisolone Acetate 1% Alone or Vehicle Alone in Patients With Mi [NCT00833495]Phase 2155 participants (Actual)Interventional2009-01-31Completed
Parasitic Ulcer Treatment Trial Pilot [NCT03484507]Phase 249 participants (Actual)Interventional2018-01-01Active, not recruiting
Pre-emptive Scalp Infiltration With Ropivacaine Plus Methylprednisolone vs Ropivacaine Alone for Relief of Postoperative Pain After Craniotomy in Children (RP/MP vs RP) [NCT03636165]Phase 490 participants (Anticipated)Interventional2022-09-01Not yet recruiting
Preoperative Single-high Dose Glucocorticoid for Patients Undergoing Hip Fracture Surgery and the Effect on Postoperative Delirium. [NCT02317601]Phase 4122 participants (Actual)Interventional2014-12-31Completed
Effect of Preoperative Low-dose of Methylprednisolone on Postoperative Pain and Immune Functions After Video-assisted Thoracoscopic Surgery: A Prospective Randomized Controlled Trial [NCT03393949]Phase 4112 participants (Actual)Interventional2015-07-01Completed
A Prospective, Multi-Center, Randomized, Double-Masked, Positive Controlled, Phase 3 Clinical Trial Designed to Evaluate the Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution Compared to Prednisolone Acetate Ophthalmic Suspe [NCT02517619]Phase 3251 participants (Actual)Interventional2016-01-16Completed
Effectiveness and Safety of Efgartigimod in the Acute Phase of Neuromyelitis Optica Spectrum Disorders-a Multicentric, Controlled, Retrospective, Real-Word Study [NCT06118398]24 participants (Anticipated)Observational2023-11-05Not yet recruiting
Phase II Study of Horse Anti-Thymocyte Globulin (hATG), Cyclosporine, Methylprednisolone, and GCSF (Filgrastim or Pegfilgrastim) in Patients With Aplastic Anemia (AA), or Low/Int-1 Risk Myelodysplastic Syndrome (MDS) [NCT01624805]Phase 2100 participants (Anticipated)Interventional2012-06-25Recruiting
CORTERAS STUDY: The Effect of Corticosteroids on Early Recovery After Major Surgery in Elderly Patients [NCT05220319]Phase 4672 participants (Anticipated)Interventional2022-02-03Recruiting
The Effects of Intraoperative Local and Systemic Corticosteroid Administration on Postoperative Dysphagia After Anterior Cervical Fusion [NCT03311425]Phase 3140 participants (Actual)Interventional2014-08-01Completed
Randomized, Double-blinded, Comparison Between Ultrasound-Guided Genicular Nerve Phenol Neurolysis and Intra-articular Steroid Injections [NCT06000709]Phase 440 participants (Anticipated)Interventional2023-10-20Not yet recruiting
A Phase 2a Single-arm, Prospective, Open-label Pilot Study to Evaluate the Safety and Efficacy of Dual Costimulation Blockade With VIB4920 and Belatacept for Prophylaxis of Allograft Rejection in Adults Receiving a Kidney Transplant [NCT04046549]Phase 225 participants (Actual)Interventional2019-10-30Completed
Yale Steroid Enhanced Versus Exparel Nerveblock TKA Randomized Controlled Trial (RCT) Study [NCT05279092]Phase 2250 participants (Anticipated)Interventional2022-09-08Recruiting
Musculoskeletal Ultrasound Changes in the Plantar Fascia After a Single Injection of Platelet Rich Plasma Compared to Steroid [NCT05339542]98 participants (Actual)Interventional2022-03-10Completed
Comparison of Follow-up and Steroid Treatment Results in Intussusception in Children [NCT05640375]Phase 1/Phase 2120 participants (Anticipated)Interventional2019-12-24Recruiting
Rituximab Plus Cyclophosphamide Followed by Belimumab for the Treatment of Lupus Nephritis (ITN055AI) [NCT02260934]Phase 243 participants (Actual)Interventional2015-07-09Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00057811 (4) [back to overview]Toxic Death
NCT00057811 (4) [back to overview]Grade ≥ 3 Stomatitis
NCT00057811 (4) [back to overview]Response Rate
NCT00057811 (4) [back to overview]Minimal Residual Disease
NCT00066469 (1) [back to overview]Event-free Survival
NCT00097448 (1) [back to overview]Hearing Improvement
NCT00109928 (4) [back to overview]2-year Overall Survival Rate
NCT00109928 (4) [back to overview]Response Rate
NCT00109928 (4) [back to overview]2-year Progression-free Survival Rate
NCT00109928 (4) [back to overview]Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
NCT00128180 (10) [back to overview]Length of Time on a Ventilator
NCT00128180 (10) [back to overview]Duration of Shock and/or Pressor/Inotropic Support
NCT00128180 (10) [back to overview]Duration of Hospital Stay in Days
NCT00128180 (10) [back to overview]Development of Serum Creatinine Greater Than or Equal to 3.0 mg/dL After Study Entry
NCT00128180 (10) [back to overview]Number of Participants Who Developed Refractory Shock Despite Fluid Resuscitation After Study Entry
NCT00128180 (10) [back to overview]Number of Participants on Extracorporeal Membrane Oxygenation (ECMO)
NCT00128180 (10) [back to overview]The Proportion of Subjects Who Develop Death, PaO2/FiO2 Ratio Less Than or Equal to 55, Cardiac Index Less Than or Equal to 2.2, Pulseless Electrical Activity, Ventricular Tachycardia or Fibrillation
NCT00128180 (10) [back to overview]Duration of ICU Stays
NCT00128180 (10) [back to overview]Number of Participants With SAEs
NCT00128180 (10) [back to overview]Number of Participants Intubated and Placed on a Ventilator After Study Entry.
NCT00185692 (2) [back to overview]Engraftment of Haploidentical CD34+ Selected Blood Stem Cells in Older Patients or Those With Medical Co-morbidities Following Total Lymphoid Irradiation and Antithymocyte Globulin Transplant Conditioning
NCT00185692 (2) [back to overview]Acute Graft-versus-Host Disease (GVHD) Grade 2-4 Risk From Time of Transplant Until Day 90 Post-transplant
NCT00186628 (4) [back to overview]Chronic Graft-vs-Host Disease (cGvHD)
NCT00186628 (4) [back to overview]Incidence of Relapse
NCT00186628 (4) [back to overview]Overall Survival
NCT00186628 (4) [back to overview]Mortality
NCT00248534 (4) [back to overview]1 Year Overall Survival Rate
NCT00248534 (4) [back to overview]6-month Progression-free Survival
NCT00248534 (4) [back to overview]Number of Participants Alive at 3 Years
NCT00248534 (4) [back to overview]Percentage of Participants With Objective Response
NCT00257933 (1) [back to overview]Time Measured From the Administration of the Loading Dose of Prednisolone (2mg/kg up to Max 60mg) in the Emergency Department (ED) Until the Home Dose of Albuterol is Administered
NCT00278564 (1) [back to overview]Survival
NCT00290589 (3) [back to overview]Numerical Rating Scale (0-10), an Interval Pain Scale, on Which 0 Indicates no Pain and 10 Indicates the Worst Pain Imaginable
NCT00290589 (3) [back to overview]Functional Disability Scales
NCT00290589 (3) [back to overview]Number of Patients Using Analgesics
NCT00309907 (6) [back to overview]C-reactive Protein Levels
NCT00309907 (6) [back to overview]Survival Rate
NCT00309907 (6) [back to overview]Response of IPS (Idiopathic Pneumonia Syndrome) to Etanercept Plus Corticosteroid Therapy by Day 28.
NCT00309907 (6) [back to overview]Plasma Cytokine IL6 Level
NCT00309907 (6) [back to overview]Estimate Percentage Pulmonary Response in Patients With IPS Treated With Etanercept + Corticosteroid Therapy
NCT00309907 (6) [back to overview]Toxicity of Etanercept Plus Corticosteroid Therapy Using the Common Terminology Criteria Version 4.0
NCT00332696 (11) [back to overview]Number of Vomiting Episodes Per Day at Day1, Day 2 and Day 14
NCT00332696 (11) [back to overview]Participant's Quality of Life Using the Edmonton Scale
NCT00332696 (11) [back to overview]Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 1
NCT00332696 (11) [back to overview]Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7
NCT00332696 (11) [back to overview]Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1
NCT00332696 (11) [back to overview]Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14
NCT00332696 (11) [back to overview]Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 2
NCT00332696 (11) [back to overview]Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 3
NCT00332696 (11) [back to overview]Number of Participants With Relief From Obstruction at Day 7 and Day 14
NCT00332696 (11) [back to overview]Number of Participants With Treatment Success From Day 10 to Day 13
NCT00332696 (11) [back to overview]Number of Participants With Treatment Success From Day 5 to Day 7
NCT00345046 (1) [back to overview]Percent Change in Flare at Resolution
NCT00354172 (15) [back to overview]Number of Participants (Patients) With Chronic Graft-Versus-Host Disease
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Attained Neutrophil Engraftment
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Attained Platelet Engraftment
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Died by 12 Months
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Died by 24 Months
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Experienced Relapse by 12 Months
NCT00354172 (15) [back to overview]Number of Participants (Patients) With Successful Natural Killer Cell Expansion
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Were Disease-free and Alive at 6 Months
NCT00354172 (15) [back to overview]Number of Participants (Patients) With Acute Graft-versus-host Disease (GVHD) Grade II-IV
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Were Disease-free and Alive at 12 Months
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Experienced Relapse by 24 Months
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Died Due to Transplant.
NCT00354172 (15) [back to overview]Number of Patients Who Were Disease-free and Alive at 24 Months
NCT00354172 (15) [back to overview]Chimerism After Double Umbilical Cord Blood Transplant (UCBT)
NCT00354172 (15) [back to overview]Number of Participants (Patients) With Acute Graft-versus-Host Disease at Grade III-IV
NCT00393367 (12) [back to overview]Mean Change in Asthma Score at 2 Hours
NCT00393367 (12) [back to overview]Change in Mean Heart Rate
NCT00393367 (12) [back to overview]Serious Adverse Events
NCT00393367 (12) [back to overview]Number of Participants With Adverse Events (Non-serious).
NCT00393367 (12) [back to overview]Relapse / Readmission Numbers.
NCT00393367 (12) [back to overview]Oxygen Saturation.
NCT00393367 (12) [back to overview]Number of Subjects Remaining in the Severe Asthma Category
NCT00393367 (12) [back to overview]Number of Subjects Moving From the Severe Asthma to Mild Asthma Category
NCT00393367 (12) [back to overview]Number of Subjects Moving From the Severe Asthma to Moderate Asthma Category
NCT00393367 (12) [back to overview]Number of Patients Hospitalized
NCT00393367 (12) [back to overview]Median Change in Asthma Score 2 Hours After Intervention
NCT00393367 (12) [back to overview]Mean Change in Respiratory Rate.
NCT00423098 (10) [back to overview]Number of Patients With Treatment Failure
NCT00423098 (10) [back to overview]Number of Patients With Complete Remission
NCT00423098 (10) [back to overview]Number of Patients With Complete Remission
NCT00423098 (10) [back to overview]Number of Patients With Adverse Events and Infections
NCT00423098 (10) [back to overview]Number of Patients With Moderate to Severe Flares
NCT00423098 (10) [back to overview]Number of Patients With Partial Remission
NCT00423098 (10) [back to overview]Change From Baseline in Overall Disease Activity With British Isles Lupus Assessment Group (BILAG)
NCT00423098 (10) [back to overview]Cumulative Dose of Prednisone Equivalent Corticosteroids (CS)
NCT00423098 (10) [back to overview]Duration of Exposure to Study Medication
NCT00423098 (10) [back to overview]Change From Baseline in Overall Disease Activity With Systematic Lupus Erythematosus Disease Activity Index (SLEDAI)
NCT00424489 (1) [back to overview]Survival
NCT00443430 (3) [back to overview]Safety Profiles, Including the Number of Treatment-emergent, Serious, or Unexpected Adverse Events and Other Important Medical Events
NCT00443430 (3) [back to overview]Clinical Remission on Medication
NCT00443430 (3) [back to overview]Proportion of Participants Who Attain Inactive Disease by 6 Months
NCT00481832 (10) [back to overview]Median Time to Neutrophile Engraftment
NCT00481832 (10) [back to overview]Relapse Rate
NCT00481832 (10) [back to overview]Overall Survival (OS)
NCT00481832 (10) [back to overview]Overall Mortality Rate
NCT00481832 (10) [back to overview]Median Time to Platelet Engraftment
NCT00481832 (10) [back to overview]Incidence of Chronic Graft Versus Host Disease (GvHD)
NCT00481832 (10) [back to overview]Incidence of Chemotherapy-associated Pneumonitis
NCT00481832 (10) [back to overview]Incidence of Acute Graft Versus Host Disease (GvHD)
NCT00481832 (10) [back to overview]Event-free Survival (EFS)
NCT00481832 (10) [back to overview]Achieving Full Donor Chimerism
NCT00492973 (5) [back to overview]Length of Hospital Stay
NCT00492973 (5) [back to overview]Knee Society Scores
NCT00492973 (5) [back to overview]Knee Range of Motion
NCT00492973 (5) [back to overview]Complications, Such as Infections, Hospital Readmissions, Manipulations Under Anesthesia, Etc.
NCT00492973 (5) [back to overview]Amount of Pain Medication Taken Per Day
NCT00493064 (1) [back to overview]Number of Participants With An Improvement in Vision, as Measured by an Increase of 15 Letters on the Early Treatment Diabetic Retinopathy Study (EDTRS) Vision Chart.
NCT00521989 (1) [back to overview]Change From Baseline to Day 98 Using the WOMAC Pain Question #1
NCT00551707 (2) [back to overview]Absolute C-reactive Protein (CRP) Values at Day 98 - As Treated Population
NCT00551707 (2) [back to overview]Percent Change From Baseline to Day 98 in C-reactive Protein (CRP) Values - As Treated Population
NCT00553202 (2) [back to overview]Cumulative Incidence of NK Cell Reconstitution
NCT00553202 (2) [back to overview]Overall Survival (OS)
NCT00555464 (2) [back to overview]Response of Hemangioma (IH) to Treatment
NCT00555464 (2) [back to overview]Toxicity to Medications
NCT00557193 (10) [back to overview]Percent Probability for Event-free Survival (EFS) for Patients on Arm C at Dose Level 2 (DL2)
NCT00557193 (10) [back to overview]Percent Probability for Event-free Survival (EFS) for Patients on Arm A
NCT00557193 (10) [back to overview]Number of Patients Who Experienced Lestaurtinib-related Dose Limiting Toxicity (DLT)
NCT00557193 (10) [back to overview]Percent Probability for Event-free Survival (EFS) of MLL-R Infants Treated With Combination Chemotherapy With or Without Lestaurtinib at DL2
NCT00557193 (10) [back to overview]Percent Probability of Event Free Survival (EFS) by MRD Status and Treatment Arm
NCT00557193 (10) [back to overview]Describe FLT3 Protein Expression as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts
NCT00557193 (10) [back to overview]Pharmacodynamics PIA Levels in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy
NCT00557193 (10) [back to overview]Describe in Vitro Sensitivity as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts
NCT00557193 (10) [back to overview]Describe FLT3 Protein Expression as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts
NCT00557193 (10) [back to overview]Describe in Vitro Sensitivity as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts
NCT00568633 (8) [back to overview]Disease-free Survival (DFS)
NCT00568633 (8) [back to overview]Complete Donor Hematopoietic Cell Chimerism
NCT00568633 (8) [back to overview]Transplant-related Mortality
NCT00568633 (8) [back to overview]Relapse Rate
NCT00568633 (8) [back to overview]Patients Completing the Intended Therapy in Both Arms
NCT00568633 (8) [back to overview]Overall Survival (OS)
NCT00568633 (8) [back to overview]Non-relapse Mortality
NCT00568633 (8) [back to overview]Early Graft Loss
NCT00577993 (2) [back to overview]Number of Participants With Progression Free Survival (10 Years) by Treatment
NCT00577993 (2) [back to overview]Number of Participants With Overall Survival (10 Years) by Treatment
NCT00595335 (8) [back to overview]Graves' Ophthalmopathy Quality of Life Score Using the Short Form-12 (SF-12) Health Survey
NCT00595335 (8) [back to overview]Failure Rate
NCT00595335 (8) [back to overview]Change in Lid Fissure
NCT00595335 (8) [back to overview]Change in Disease Severity
NCT00595335 (8) [back to overview]Failure Rate at One Year
NCT00595335 (8) [back to overview]Change in Clinical Activity Score (CAS)
NCT00595335 (8) [back to overview]Change in Proptosis
NCT00595335 (8) [back to overview]Change in Extraocular Motility
NCT00609609 (3) [back to overview]Day 56 Treatment Success
NCT00609609 (3) [back to overview]Non-relapse Mortality (NRM) at 6 Months
NCT00609609 (3) [back to overview]Percentage of Participants Alive, In Remission & Without GVHD Progression Day 28 & Day 56
NCT00624416 (3) [back to overview]The Number of Lipoma Increased in Volume.
NCT00624416 (3) [back to overview]The Number of Subjects Elected to Have the Lipoma Removed.
NCT00624416 (3) [back to overview]The Average Percent Volume Reduction in the Lipoma.
NCT00634933 (12) [back to overview]Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
NCT00634933 (12) [back to overview]Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
NCT00634933 (12) [back to overview]Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
NCT00634933 (12) [back to overview]Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28
NCT00634933 (12) [back to overview]Physician Global Assessment (PGA) of Disease Activity
NCT00634933 (12) [back to overview]Visual Analogue Scale for Pain (VAS-pain)
NCT00634933 (12) [back to overview]Percentage of Participants With an American College of Rheumatology 50% (ACR 50) Response at Week 24
NCT00634933 (12) [back to overview]Number of Tender Joints
NCT00634933 (12) [back to overview]Number of Swollen Joints
NCT00634933 (12) [back to overview]Patient Global Assessment (PtGA) of Disease Activity
NCT00634933 (12) [back to overview]Health Assessment Questionnaire Disability Index (HAQ-DI)
NCT00634933 (12) [back to overview]Disease Activity Score Based on 28-joints Count (DAS28)
NCT00671658 (1) [back to overview]Number of Participants With a Response
NCT00682357 (4) [back to overview]Change in Serum Osteocalcin
NCT00682357 (4) [back to overview]Change in Serum Cortisol
NCT00682357 (4) [back to overview]Change in Testosterone
NCT00682357 (4) [back to overview]Change in Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b)
NCT00689078 (10) [back to overview]Ocular Itching at Baseline (Day 0)
NCT00689078 (10) [back to overview]Ocular Itching at Day 7
NCT00689078 (10) [back to overview]Ocular Redness at Day 6
NCT00689078 (10) [back to overview]Ocular Redness at Day 28
NCT00689078 (10) [back to overview]Ocular Redness at Day 27
NCT00689078 (10) [back to overview]Ocular Itching at Day 27
NCT00689078 (10) [back to overview]Ocular Redness at Baseline (Day 0)
NCT00689078 (10) [back to overview]Ocular Itching at Day 6
NCT00689078 (10) [back to overview]Ocular Itching at Day 28
NCT00689078 (10) [back to overview]Ocular Redness at Day 7
NCT00699803 (1) [back to overview]Mean Aqueous Humor Prednisolone Acetate Concentration
NCT00720109 (5) [back to overview]Overall EFS Rate for the Combined Cohort of Standard- and High-Risk Patients (Who Receive the Final Chosen Dose of Dasatinib)
NCT00720109 (5) [back to overview]Contribution of Dasatinib on Minimal Residual Disease (MRD) After Induction Therapy
NCT00720109 (5) [back to overview]Event-Free Survival (EFS) of Patients With Standard-risk Disease Treated With Dasatinib in Combination With Intensified Chemotherapy
NCT00720109 (5) [back to overview]Feasibility and Toxicity of an Intensified Chemotherapeutic Regimen Incorporating Dasatinib for Treatment of Children and Adolescents With Ph+ ALL Assessed by Examining Adverse Events
NCT00720109 (5) [back to overview]Percent of Patients MRD Positive (MRD > 0.01%) at End of Consolidation
NCT00732498 (4) [back to overview]Complete Response Rate
NCT00732498 (4) [back to overview]Median Time to Progression
NCT00732498 (4) [back to overview]Progression-free Survival at 1 Year
NCT00732498 (4) [back to overview]Overall Response Rate
NCT00733096 (4) [back to overview]Global Perceived Effect
NCT00733096 (4) [back to overview]Medication Reduction
NCT00733096 (4) [back to overview]Oswestry Disability Score
NCT00733096 (4) [back to overview]Numerical Rating Leg Pain Score
NCT00782717 (2) [back to overview]Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery
NCT00782717 (2) [back to overview]Percent of Patients With a Decrease of More Than 5 Letters in Best-corrected Visual Acuity (BCVA).
NCT00787722 (6) [back to overview]Survival
NCT00787722 (6) [back to overview]Quality of Life (QOL) Short Form - 36 (SF-36)
NCT00787722 (6) [back to overview]Disability Score: Expanded Disability Status Scale (EDSS)
NCT00787722 (6) [back to overview]NMO-IgG Aquaporin- 4 Autoantibody Titer
NCT00787722 (6) [back to overview]Number of Patients Who Require No Device Assistance for Ambulation
NCT00787722 (6) [back to overview]Post HSCT Immune -Modulating Medication and Relapse
NCT00792948 (3) [back to overview]Relapse-free Survival (RFS) After Allogeneic Stem Cell Transplantation
NCT00792948 (3) [back to overview]Overall Survival (OS)
NCT00792948 (3) [back to overview]Continuous Complete Remission (CCR) Rate
NCT00802529 (3) [back to overview]Change in Hearing
NCT00802529 (3) [back to overview]Vertigo Attacks
NCT00802529 (3) [back to overview]Change in Speech Discrimination
NCT00806598 (1) [back to overview]Overall Response
NCT00807586 (3) [back to overview]Number of Participants With Clinically Significant Atrial Arrhythmias at 6 Weeks
NCT00807586 (3) [back to overview]Cardiac Pain Assessment
NCT00807586 (3) [back to overview]Repeat Intervention
NCT00854061 (1) [back to overview]Means Aqueous Humor Prednisolone Acetate Concentration
NCT00908583 (4) [back to overview]Number of Living Donor Transplant Candidates That Are Transplanted
NCT00908583 (4) [back to overview]Acute Rejection Rate
NCT00908583 (4) [back to overview]Overall Safety of Bortezomib
NCT00908583 (4) [back to overview]Number of Patients Whose Cytotoxic Panel Reactive Antibody (PRA) is Decreased by 50%
NCT00915473 (4) [back to overview]Number of Subjects With at Least 50% Reduction in the Frequency of Days With Moderate or Severe Migraine in the 4 Week Post Injection Compared to the 4 Week Pre-injection Baseline Period
NCT00915473 (4) [back to overview]Mean Frequency of Days With a Migraine
NCT00915473 (4) [back to overview]Mean Number of Days With Acute Medication Use
NCT00915473 (4) [back to overview]Mean Number of Hours With Moderate or Severe Migraine
NCT00929695 (12) [back to overview]Prednisone-associated Toxicity as Assessed by Myopathy
NCT00929695 (12) [back to overview]Prednisone-associated Toxicity as Assessed by Quality of Life
NCT00929695 (12) [back to overview]Progression to Grade III-IV Acute GVHD
NCT00929695 (12) [back to overview]Secondary Therapy for Acute GVHD Beyond Prednisone
NCT00929695 (12) [back to overview]Recurrent or Progressive Malignancy
NCT00929695 (12) [back to overview]Chronic Extensive GVHD
NCT00929695 (12) [back to overview]Mean Cumulative Prednisone Dose (mg/kg) Over 42 Days From the Start of Treatment
NCT00929695 (12) [back to overview]Non-relapse Mortality
NCT00929695 (12) [back to overview]Overall Survival
NCT00929695 (12) [back to overview]Prednisone-associated Toxicity as Assessed by Hypertension
NCT00929695 (12) [back to overview]Prednisone-associated Toxicity as Assessed by Hyperglycemia
NCT00929695 (12) [back to overview]Prednisone-associated Toxicity as Assessed by Invasive Infections (Bacterial, Fungal and Viral)
NCT00929981 (7) [back to overview]Treatment Status (Success/Failure) of CD at the Third Follow-up Visit
NCT00929981 (7) [back to overview]Treatment Status (Success/Failure) of Contact Dermatitis (CD) at the Second Follow-up Visit
NCT00929981 (7) [back to overview]Change From Baseline in Participant-rated Clinical Severity Score of Lesions at First, Second, Third and Final Follow-up Visits
NCT00929981 (7) [back to overview]Change From Baseline in Participant-rated Pruritus Score at First, Second, Third and Final Follow-up Visits
NCT00929981 (7) [back to overview]Change From Baseline in Investigator-rated Total Signs and Symptoms of CD Score at First, Second, Third and Final Follow-up Visits
NCT00929981 (7) [back to overview]Treatment Status (Success/Failure) of CD at the Final Follow-up Visit
NCT00929981 (7) [back to overview]Treatment Status (Success/Failure) of CD at the First Follow-up Visit
NCT00934843 (5) [back to overview]Primary Endpoint: Number of Participants With Low Cardiac Output Syndrome (LCOS) or Death at 36 Hours From Admission to the Intensive Care Unit (ICU) After Surgery.
NCT00934843 (5) [back to overview]Number of Participants Who Died Between 36 Hours and 30 Days Following Cardiac Surgery
NCT00934843 (5) [back to overview]Inotropic Score
NCT00934843 (5) [back to overview]Total Intake/Output of Fluid
NCT00934843 (5) [back to overview]Urine Output
NCT00947765 (8) [back to overview]Pain(at 6 Months): Nirschl Staging
NCT00947765 (8) [back to overview]Pain(at 4 Weeks): Visual Analogue Scale
NCT00947765 (8) [back to overview]Pain(at 12 Weeks): Visual Analogue Scale
NCT00947765 (8) [back to overview]Pain(at 12 Weeks): Nirschl Staging
NCT00947765 (8) [back to overview]Pain(at 1 Week): Nirschl Staging (0 to 7)
NCT00947765 (8) [back to overview]Pain (at 1 Week): Visual Analogue Scale(0 to 10)
NCT00947765 (8) [back to overview]Pain(at 4 Weeks): Nirschl Staging
NCT00947765 (8) [back to overview]Pain(at 6 Months): Visual Analogue Scale
NCT00957801 (40) [back to overview]Cortisol Measured on Treatment Day 1 (Baseline Study) BEFORE Exercise Protocol
NCT00957801 (40) [back to overview]Cortisol Measured on Treatment Day 8 (Post Study) AFTER Exercise Protocol
NCT00957801 (40) [back to overview]Cortisol Measured on Treatment Day 8 (Post Study) BEFORE Exercise Protocol
NCT00957801 (40) [back to overview]Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) During the Treatment Week
NCT00957801 (40) [back to overview]Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) in the Pre-treatment Week
NCT00957801 (40) [back to overview]Hematocrit Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Hematocrit Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]C-Reactive Protein (CRP) Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]High-Density Lipoproteins (HDL) Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Insulin Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Insulin Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Low-Density Lipoproteins (LDL) Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Low-Density Lipoproteins (LDL) Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Cortisol Measured on Treatment Day 1 (Baseline Study) AFTER Exercise Protocol
NCT00957801 (40) [back to overview]Prostate Specific Antigen (PSA) Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Prostate Specific Antigen (PSA) Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Serum Estradiol Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Serum Estradiol Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Serum Total Testosterone Measured Before Treatment on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Serum Total Testosterone Measured on Treatment Day 2
NCT00957801 (40) [back to overview]Serum Total Testosterone Measured on Treatment Day 3
NCT00957801 (40) [back to overview]Serum Total Testosterone Measured on Treatment Day 4
NCT00957801 (40) [back to overview]Serum Total Testosterone Measured on Treatment Day 5
NCT00957801 (40) [back to overview]Serum Total Testosterone Measured on Treatment Day 6
NCT00957801 (40) [back to overview]Serum Total Testosterone Measured on Treatment Day 7
NCT00957801 (40) [back to overview]Serum Total Testosterone Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Total Cholesterol Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Total Cholesterol Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]High-Density Lipoproteins (HDL) Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Triglycerides Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Triglycerides Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]C-Reactive Protein (CRP) Measured on Treatment Day 1 (Baseline Study)
NCT00967226 (13) [back to overview]Allergy/Immunology Adverse Events
NCT00967226 (13) [back to overview]Growth and Development Adverse Events
NCT00967226 (13) [back to overview]Metabolic or Laboratory AEs
NCT00967226 (13) [back to overview]Infectious Adverse Events
NCT00967226 (13) [back to overview]Gastrointestinal Adverse Events
NCT00967226 (13) [back to overview]Endocrinologic Adverse Events
NCT00967226 (13) [back to overview]Dermatologic Adverse Events
NCT00967226 (13) [back to overview]Decrease in Size of Hemangioma (Length x Width) in Square mm
NCT00967226 (13) [back to overview]Number of Serious Adverse Events (SAEs)
NCT00967226 (13) [back to overview]Vascular Adverse Events
NCT00967226 (13) [back to overview]Pulmonary/Respiratory Adverse Events
NCT00967226 (13) [back to overview]Tolerability of Medication
NCT00967226 (13) [back to overview]Constitutional Adverse Events
NCT00968253 (3) [back to overview]Maximum Tolerated Dose [MTD] Determination by Number of Participants With Dose Limiting Toxicity (DLT)
NCT00968253 (3) [back to overview]Overall Response Rate (OR) Where OR = CR + CRp + CRi
NCT00968253 (3) [back to overview]Participant Responses by Daily Dose Level Assignment (RAD001 5 mg, 10 mg and MTD 5 mg)
NCT01000610 (4) [back to overview]Change in Bone Density (in Participants Untreated With Bisphosphonates)
NCT01000610 (4) [back to overview]Number of Participants Reporting Adverse Events (AEs)
NCT01000610 (4) [back to overview]Percentage Change in Disease Activity Score 28 (DAS28) From Baseline to Week 24
NCT01000610 (4) [back to overview]Percentage of Participants Whose DAS28 Improved by >1.2 at Week 24
NCT01085097 (2) [back to overview]Percent Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24
NCT01085097 (2) [back to overview]Number of Participants With Adverse Events (AEs)
NCT01093586 (14) [back to overview]Transplant Related Mortality
NCT01093586 (14) [back to overview]Disease Free
NCT01093586 (14) [back to overview]Transplant Related Mortality
NCT01093586 (14) [back to overview]Toxicity Related to UCB Transplantation and Cytoreduction as Assessed by CTC v3.0
NCT01093586 (14) [back to overview]Recurrence or Relapse
NCT01093586 (14) [back to overview]Recurrence or Relapse
NCT01093586 (14) [back to overview]Overall Survival
NCT01093586 (14) [back to overview]Overall Survival
NCT01093586 (14) [back to overview]Overall Survival
NCT01093586 (14) [back to overview]Occurrence of Serious Infections
NCT01093586 (14) [back to overview]Incidence of Chronic GVHD
NCT01093586 (14) [back to overview]Incidence of Acute Graft-versus-host Disease (GVHD)
NCT01093586 (14) [back to overview]Disease Free
NCT01093586 (14) [back to overview]Hematologic Engraftment
NCT01105650 (4) [back to overview]Response Rate
NCT01105650 (4) [back to overview]Time to Disease Progression
NCT01105650 (4) [back to overview]Overall Survival
NCT01105650 (4) [back to overview]Number of Participants With Progressive Disease at One Year
NCT01114503 (8) [back to overview]Number of Participants With an Epstein Barr Virus (EBV) Viral Load Abnormalities Meeting the Criteria for PCC
NCT01114503 (8) [back to overview]Number of Participants With Electrocardiogram (ECG) Abnormalities Meeting the Criteria for PCC
NCT01114503 (8) [back to overview]Number of Participants With Laboratory Clinical Chemistry Abnormalities Meeting the Criteria for Potential Clinical Concern (PCC)
NCT01114503 (8) [back to overview]Number of Participants With Laboratory Hematology Abnormalities Meeting the Criteria for PCC
NCT01114503 (8) [back to overview]Number of Participants With Laboratory Urinalysis Abnormalities Meeting the Criteria for PCC
NCT01114503 (8) [back to overview]Number of Participants With Thyroid Function Assessment, Hormone and Glucose Assay Abnormalities Meeting the Criteria for PCC
NCT01114503 (8) [back to overview]Number of Participants With Vital Signs Abnormalities Meeting the Criteria for PCC
NCT01114503 (8) [back to overview]Number of Participants With at Least One Adverse Event (AE), Serious Adverse Event (SAE), or Drug-related Adverse Event
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity
NCT01124045 (13) [back to overview]Global Assessment Score of Postoperative Inflammation by Visit
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon
NCT01124045 (13) [back to overview]Percentage of Patients With an Anterior Cell Grade of 0 (no Cells) at Day 15 ± 2 Days
NCT01144143 (5) [back to overview]Change in Serum SAA Levels Day 0 to Day 56
NCT01144143 (5) [back to overview]Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score Target Knee
NCT01144143 (5) [back to overview]Change in Joint Effusions From Day 0 to Day 56 Target Knee
NCT01144143 (5) [back to overview]Change in Levels of Serum IL-6
NCT01144143 (5) [back to overview]Change in Serum CRP Day 0 to Day 56
NCT01201798 (10) [back to overview]Proportion of Subjects Who Discontinued Due to Lack of Efficacy
NCT01201798 (10) [back to overview]Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14
NCT01201798 (10) [back to overview]Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0
NCT01201798 (10) [back to overview]Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14
NCT01201798 (10) [back to overview]Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points
NCT01201798 (10) [back to overview]Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points
NCT01201798 (10) [back to overview]Proportion of Subjects With Anterior Chamber Cell Count of 0
NCT01201798 (10) [back to overview]Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits
NCT01201798 (10) [back to overview]Proportion of Subjects With Anterior Chamber Cell Grade ≤1
NCT01201798 (10) [back to overview]Proportion of Subjects With Anterior Chamber Cell Grade of 0
NCT01211665 (3) [back to overview]Number of Participants Who Survived at 6 Months Following Completion of Plasma Exchange (PLEX)
NCT01211665 (3) [back to overview]Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT01211665 (3) [back to overview]Severity of AEs and SAEs
NCT01219933 (33) [back to overview]Median Dose of Tocilizumab During the Noninterventional Phase
NCT01219933 (33) [back to overview]Median Time Interval Between V1 and V2
NCT01219933 (33) [back to overview]Number of Participants With Changes in Tocilizumab Dose During the Noninterventional Phase
NCT01219933 (33) [back to overview]Number of Participants With GC Switches During the Noninterventional Phase
NCT01219933 (33) [back to overview]Percentage of Participants Able to Acheive LDA Assessed Using DAS28 While Receiving Oral GC on Background Tocilizumab Treatment During the Noninterventional Phase
NCT01219933 (33) [back to overview]Percentage of Participants Able to Discontinue GCs During the Interventional Phase by V9
NCT01219933 (33) [back to overview]Percentage of Participants Able to Reduce Oral GCs by ≥50 Percent (%) During the Interventional Phase by V9
NCT01219933 (33) [back to overview]Percentage of Participants Acheiving Remission Assessed Using DAS28 While Receiving Oral GC on Background TocilizumabTreatment During the Noninterventional Phase
NCT01219933 (33) [back to overview]Percentage of Participants Able to Start the GC Reduction Phase at V3
NCT01219933 (33) [back to overview]Percentage of Participants in the Interventional Phase Who Achieved LDA and Discontinued Oral GC Within 20 Weeks
NCT01219933 (33) [back to overview]Percentage of Participants With Changes in RA Treatment During the Noninterventional Phase
NCT01219933 (33) [back to overview]Time-Averaged GC Dose Changes During the Interventional Phase
NCT01219933 (33) [back to overview]CDAI Score During the Interventional Phase
NCT01219933 (33) [back to overview]Clinical Disease Activity Index (CDAI) During the Noninterventional Phase
NCT01219933 (33) [back to overview]DAS28-CRP During the Interventional Phase
NCT01219933 (33) [back to overview]SJC and TJC During the Interventional Phase
NCT01219933 (33) [back to overview]Percentage of Participants Positive for Rheumatoid Factor (RF) During the Noninterventional Phase
NCT01219933 (33) [back to overview]DAS28-CRP During the Noninterventional Phase
NCT01219933 (33) [back to overview]DAS28-ESR During the Noninterventional Phase
NCT01219933 (33) [back to overview]Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score During the Interventional Phase
NCT01219933 (33) [back to overview]Percentage of Participants With LDA or Remission During the Interventional Phase Assessed Using DAS28-CRP
NCT01219933 (33) [back to overview]VAS-Physician's Global Assessment of Disease Activity (GDA) During the Interventional Phase
NCT01219933 (33) [back to overview]VAS for Pain (VAS-Pain) During the Interventional Phase
NCT01219933 (33) [back to overview]Percentage of Participants Positive for Anti-cyclic Citrullinated Peptide (Anti-CCP) Antibody During the Noninterventional Phase
NCT01219933 (33) [back to overview]Type of GC Taken at the End of the Noninterventional Phase
NCT01219933 (33) [back to overview]HAQ-DI During the Interventional Phase
NCT01219933 (33) [back to overview]Health Assessment Questionnaire Disability Index (HAQ-DI) During the Noninterventional Phase
NCT01219933 (33) [back to overview]Median GC Dose Taken During the Noninterventional Phase
NCT01219933 (33) [back to overview]Number of Erosions During the NonInterventional Phase
NCT01219933 (33) [back to overview]Short-Form 36 (SF-36) Mental Component Score (MCS) and Physical Component Score (PCS) During the Interventional Phase
NCT01219933 (33) [back to overview]Percentage of Participants With Erosions During the NonInterventional Phase
NCT01219933 (33) [back to overview]Percentage of Participants With LDA or Remission During the Interventional Phase Assessed Using CDAI
NCT01219933 (33) [back to overview]SF-36 Subscale Scores During the Interventional Phase
NCT01267201 (4) [back to overview]Plasma Decay Half-life (t1/2)
NCT01267201 (4) [back to overview]Time to Reach Maximum Observed Plasma Concentration (Tmax)
NCT01267201 (4) [back to overview]Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
NCT01267201 (4) [back to overview]Maximum Observed Plasma Concentration (Cmax)
NCT01272635 (5) [back to overview]Progression to Clinically Significant Lower Respiratory Tract Symptoms
NCT01272635 (5) [back to overview]OCELOT: Pediatric Respiratory Assessment Measure
NCT01272635 (5) [back to overview]Drug Related Side Effects
NCT01272635 (5) [back to overview]Asthma Related Symptoms Among RTI Progressing to Severe LRTI
NCT01272635 (5) [back to overview]Urgent Care Visits, ED Visits and Hospitalizations
NCT01283009 (1) [back to overview]60-day Mortality
NCT01319981 (3) [back to overview]Overall Survival
NCT01319981 (3) [back to overview]Number of Patients With Complete Remission at One Year
NCT01319981 (3) [back to overview]Complete Response Duration
NCT01369745 (1) [back to overview]Change From Baseline in DAS28-CRP at 12 Weeks
NCT01381874 (7) [back to overview]Change From Baseline in Serum Endocrine Biomarkers (Progesterone and Testosterone) at End of Treatment
NCT01381874 (7) [back to overview]Overall Response Rate (ORR)
NCT01381874 (7) [back to overview]Change From Baseline in Serum Endocrine Biomarkers (Estradiol and Estrone) at End of Treatment
NCT01381874 (7) [back to overview]Duration of Response
NCT01381874 (7) [back to overview]Clinical Benefit Rate
NCT01381874 (7) [back to overview]Progression-Free Survival (PFS)
NCT01381874 (7) [back to overview]Overall Survival (OS)
NCT01448213 (2) [back to overview]Number of Eyes With Intraocular Pressure (IOP) Elevation
NCT01448213 (2) [back to overview]Number of Eyes With Immunologic Graft Rejection Episodes
NCT01465334 (11) [back to overview]Number of Participants Completing Part A Treatment
NCT01465334 (11) [back to overview]Number of Participants With Treatment-Related Grades 1-3 Hyperglycemia During Part A Induction
NCT01465334 (11) [back to overview]Number of Participants Achieving Induction Complete Response (CR)
NCT01465334 (11) [back to overview]Induction Overall Response Rate (ORR)
NCT01465334 (11) [back to overview]3-Year Progression-Free Survival (PFS) Probability
NCT01465334 (11) [back to overview]3-year Overall Survival (OS) Probability
NCT01465334 (11) [back to overview]Number of Participants With Overall CR
NCT01465334 (11) [back to overview]Number of Participants Completing Only 2 Cycles of Part A Treatment
NCT01465334 (11) [back to overview]Transplant Rate
NCT01465334 (11) [back to overview]Overall Objective Response Rate (ORR)
NCT01465334 (11) [back to overview]Overall MRD Negative Rate
NCT01475643 (2) [back to overview]Anterior Chamber Inflammation
NCT01475643 (2) [back to overview]Anterior Chamber Cells & Flare
NCT01496976 (4) [back to overview]Number of Participants With Overall Survival (OS)
NCT01496976 (4) [back to overview]Rate of Progression/Relapse Free Survival (PFS)
NCT01496976 (4) [back to overview]Number of Participants With Complete Response (CR)
NCT01496976 (4) [back to overview]Number of Participants With Partial Response (PR)
NCT01497496 (1) [back to overview]Objective Response Rate (ORR)
NCT01534195 (4) [back to overview]Episcleral Redness Change From Baseline to Day 6
NCT01534195 (4) [back to overview]Ciliary Redness Change From Baseline to Day 6
NCT01534195 (4) [back to overview]Ocular Itching Change From Baseline to Day 11
NCT01534195 (4) [back to overview]Conjunctival Redness Change From Baseline to Day 11
NCT01559675 (1) [back to overview]Orthostatic Hypotension
NCT01579513 (5) [back to overview]Neurodevelopmental Outcome
NCT01579513 (5) [back to overview]Hospital Stay
NCT01579513 (5) [back to overview]Intensive Care Unit Stay
NCT01579513 (5) [back to overview]Duration of Mechanical Ventilation Post Cardiac Surgery.
NCT01579513 (5) [back to overview]Number of Participants With a Clinically Derived Composite Morbidity-mortality Outcome
NCT01652495 (3) [back to overview]Percentage of Patients With Suppression of Hypothalamus-pituitary-adrenal Axis
NCT01652495 (3) [back to overview]Reduction of Pain Severity Expressed as Percentage Change in VAS Score
NCT01652495 (3) [back to overview]Functional Improvement Measured According to Percentage Change in Constant Score
NCT01724021 (14) [back to overview]Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 8
NCT01724021 (14) [back to overview]Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 6
NCT01724021 (14) [back to overview]Event-free Survival (EFS)
NCT01724021 (14) [back to overview]Percentage of Participants With Anti-Rituximab Antibodies Over Time
NCT01724021 (14) [back to overview]Number of Participants With Treatment Emergent Adverse Events (AEs)
NCT01724021 (14) [back to overview]Overall Survival (OS)
NCT01724021 (14) [back to overview]Complete Response (CR) Rate
NCT01724021 (14) [back to overview]Time Required for Rituximab Administration (Subcutaneous [SC] or Intravenous [IV])
NCT01724021 (14) [back to overview]Cancer Therapy Satisfaction Questionnaire (CTSQ) Score
NCT01724021 (14) [back to overview]Percentage of Participants With Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies Over Time
NCT01724021 (14) [back to overview]Rituximab Administration Satisfaction Questionnaire (RASQ) Score
NCT01724021 (14) [back to overview]Summary of Observed Serum Rituximab Concentration
NCT01724021 (14) [back to overview]Disease-free Survival (DFS)
NCT01724021 (14) [back to overview]Progression-free Survival (PFS)
NCT01730872 (3) [back to overview]Ocular Redness Change From Baseline to Day 6
NCT01730872 (3) [back to overview]Ocular Itching Change From Baseline to Day 6
NCT01730872 (3) [back to overview]Inflammation Change From Baseline to Day 6
NCT01783847 (2) [back to overview]Number of Participants With Change/Improvement Visual Acuity From the Beseline
NCT01783847 (2) [back to overview]Number of Participants With Relative Afferent Papillary Defect (RAPD) Grade +4
NCT01809132 (4) [back to overview]MELD Score at 90 Days
NCT01809132 (4) [back to overview]MELD Score at 28 Days
NCT01809132 (4) [back to overview]180 Days Mortality
NCT01809132 (4) [back to overview]MELD Score at 180 Days
NCT01853072 (6) [back to overview]Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit
NCT01853072 (6) [back to overview]Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit [Time Frame: Day 7 up to Any Visit]
NCT01853072 (6) [back to overview]Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)
NCT01853072 (6) [back to overview]Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60
NCT01853072 (6) [back to overview]Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90
NCT01853072 (6) [back to overview]Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90
NCT01853696 (2) [back to overview]Intraocular Pressure
NCT01853696 (2) [back to overview]Immunologic Graft Rejection Episode
NCT01872611 (6) [back to overview]Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit
NCT01872611 (6) [back to overview]Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90
NCT01872611 (6) [back to overview]Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90
NCT01872611 (6) [back to overview]Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60
NCT01872611 (6) [back to overview]Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)
NCT01872611 (6) [back to overview]Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit
NCT01875237 (8) [back to overview]To Assess Post Donor Lymphocyte Infusion (DLI) Chimerism
NCT01875237 (8) [back to overview]To Assess the Incidence of Acute GvHD Flare After CR/PR Requiring Additional Agent for Systemic Therapy Before Day 56 Post-administration of AP1903.
NCT01875237 (8) [back to overview]To Assess the Incidence of Epstein-Barr Virus -PTLD or EBV Reactivation Requiring Therapy Post DLI.
NCT01875237 (8) [back to overview]To Evaluate the Safety of Donor Lymphocyte Infusion Followed by Dimerizer Drug, AP1903 by Number of Participants With Adverse Events.
NCT01875237 (8) [back to overview]Number of Participants Assessed Post Donor Lymphocyte Infusion (DLI): Disease-free Survival & Non-relapse Mortality, Chimerism and GVHD.
NCT01875237 (8) [back to overview]To Assess the Incidence of GvHD Treatment Failure Post-administration of AP1903.
NCT01875237 (8) [back to overview]To Assess the Proportion of Patients Developing Grade I-IV Acute GvHD
NCT01875237 (8) [back to overview]To Assess the Proportions of GvHD Response Post-administration of AP1903.
NCT01897571 (4) [back to overview]Recommended Phase 2 Dose (RP2D) of Tazemetostat as a Single-Agent and in Combination With Prednisolone (Phase 1 Only)
NCT01897571 (4) [back to overview]Duration of Response for Tazemetostat as a Single Agent or in Combination With Prednisolone (Phase 2 Only)
NCT01897571 (4) [back to overview]Objective Response Rate (ORR; Complete Response + Partial Response [CR + PR]) (Phase 2)
NCT01897571 (4) [back to overview]Progression Free Survival for Tazemetostat as a Single Agent or in Combination With Prednisolone (Phase 2 Only)
NCT01977781 (7) [back to overview]Ocular Burning Sensation, Ocular Discharge, Ocular Redness, Ocular Itching, Foreign Body Sensation
NCT01977781 (7) [back to overview]Corneal Epitheliopathy (Corneal Fluorescein Staining Using the NEI Grading Scheme)
NCT01977781 (7) [back to overview]Intraocular Pressure
NCT01977781 (7) [back to overview]Visual Acuity
NCT01977781 (7) [back to overview]Tear Film Break-Up Time
NCT01977781 (7) [back to overview]Ocular Surface Disease Index (OSDI) Questionnaire
NCT01977781 (7) [back to overview]Schirmer Tear Test (mm)
NCT02006706 (2) [back to overview]Change From Baseline Disease Activity Score Based on 28-Joint Count (DAS28) at Week 24
NCT02006706 (2) [back to overview]Health Assessment Questionnaire-Disability Index (HAQ-DI)
NCT02038452 (44) [back to overview]QALYS at 12 Months (Cross-walk Tariff)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations 6 Weeks (Subgroup Analysis (SG), Intervention of Their Preference)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Preferred Splint)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Preferred Injection)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Did Not State a Preference of Intervention)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Did Not Receive the Intervention of Their Preference)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations 6 Weeks (Per-Protocol Analysis (PP))
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations 6 Weeks (Complete Case Analysis (CC))
NCT02038452 (44) [back to overview]Hand-wrist Pain Intensity Over 24 Months: 6 Weeks
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations 6 Months (PP)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations 6 Months (CC)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations 6 Months
NCT02038452 (44) [back to overview]BCTQ Functional Limitations Subscale 6 Weeks (PP)
NCT02038452 (44) [back to overview]Symptom Severity and Limitations in Hand Function as Assessed by the BCTQ 6 Weeks
NCT02038452 (44) [back to overview]Secondary: BCTQ Symptom Severity and Functional Limitations Over 24 Months: 24 Months
NCT02038452 (44) [back to overview]QALYS at 6 Months (Cross-walk Tariff)
NCT02038452 (44) [back to overview]QALYS at 24 Months (Cross-walk Tariff)
NCT02038452 (44) [back to overview]BCTQ Functional Limitations Subscale 6 Weeks
NCT02038452 (44) [back to overview]NHS Cost Differences at 6 Months (CC)
NCT02038452 (44) [back to overview]NHS Cost Differences at 6 Months
NCT02038452 (44) [back to overview]NHS Cost Differences at 24 Months
NCT02038452 (44) [back to overview]NHS Cost Differences at 12 Months
NCT02038452 (44) [back to overview]Hand-wrist Pain Intensity Over 24 Months: 6 Months
NCT02038452 (44) [back to overview]Hand-wrist Pain Intensity Over 24 Months: 24 Months
NCT02038452 (44) [back to overview]Hand-wrist Pain Intensity Over 24 Months: 12 Months
NCT02038452 (44) [back to overview]Hand-wrist Pain Intensity 6 Weeks (PP)
NCT02038452 (44) [back to overview]Hand-wrist Pain Intensity 6 Weeks (CC)
NCT02038452 (44) [back to overview]Hand-wrist Pain Intensity 6 Weeks
NCT02038452 (44) [back to overview]Hand-wrist Pain Intensity 6 Months (PP)
NCT02038452 (44) [back to overview]Hand-wrist Pain Intensity 6 Months (CC)
NCT02038452 (44) [back to overview]Hand-wrist Pain Intensity 6 Months
NCT02038452 (44) [back to overview]BCTQ Symptom Severity Subscale 6 Weeks (PP)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity Subscale 6 Weeks (CC)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations Over 24 Months: 6 Weeks
NCT02038452 (44) [back to overview]BCTQ Symptom Severity Subscale 6 Months (PP)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity Subscale 6 Months (CC)
NCT02038452 (44) [back to overview]BCTQ Functional Limitations Subscale 6 Weeks (CC)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations Over 24 Months: 12 Months
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations Over 24 Months: 6 Months
NCT02038452 (44) [back to overview]BCTQ Symptom Severity Subscale 6 Weeks
NCT02038452 (44) [back to overview]BCTQ Functional Limitations Subscale 6 Months
NCT02038452 (44) [back to overview]BCTQ Functional Limitations Subscale 6 Months (CC)
NCT02038452 (44) [back to overview]BCTQ Functional Limitations Subscale 6 Months (PP)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity Subscale 6 Months
NCT02166463 (3) [back to overview]Percentages of Patients With Early Response Defined as no Slow Responding Lesions (SRL) and no Progressive Disease (PD) at Any Disease Sites Determined by Positron Emission Tomography (PET) Per Deauville Criteria Through Central Review
NCT02166463 (3) [back to overview]Event Free Survival (EFS), Where Events Include Disease Progression or Relapse, Second Malignancy, or Death
NCT02166463 (3) [back to overview]Percentages of Patients Experiencing Grade 3+ Peripheral Neuropathy Assessed by Modified Balis Scale
NCT02167217 (1) [back to overview]Bayley III Gross Motor Scaled Score (Change From Baseline to 12 Month)
NCT02176031 (6) [back to overview]Overall Survival (OS) Rate
NCT02176031 (6) [back to overview]GVHD-free Survival Rate
NCT02176031 (6) [back to overview]GI aGVHD Response Rate
NCT02176031 (6) [back to overview]Rate of GVHD Flares
NCT02176031 (6) [back to overview]Percentage Steroid Dose Was Reduced at Day 28, 56, and 100 in Comparison to Steroid Dose at First Administration of Natalizumab.
NCT02176031 (6) [back to overview]Graft-verus-host Disease (GVHD) Response Rate
NCT02199041 (9) [back to overview]Number of Participants With Secondary Graft Failure
NCT02199041 (9) [back to overview]Number of Participants With Event-free Survival (EFS)
NCT02199041 (9) [back to overview]Number of Participants With Malignant Relapse
NCT02199041 (9) [back to overview]Number of Participants With Neutrophil Engraftment
NCT02199041 (9) [back to overview]Number of Participants With Transplant-related Mortality (TRM)
NCT02199041 (9) [back to overview]Number of Participants by Severity With Acute Graft Versus Host Disease (GVHD) in the First 100 Days After HCT
NCT02199041 (9) [back to overview]Number of Participants by Severity With Chronic Graft Versus Host Disease (GVHD) in the First 100 Days After HCT
NCT02199041 (9) [back to overview]Number of Participants With Transplant-related Morbidity
NCT02199041 (9) [back to overview]Number of Participants With Overall Survival (OS)
NCT02242630 (2) [back to overview]Change in Subject Reported Shoulder Pain as Measured by the Visual Analogue Scale
NCT02242630 (2) [back to overview]Change in Shoulder Function, as Measured by the QuickDASH ®
NCT02256969 (4) [back to overview]Ocular Surface Disease Index (OSDI)
NCT02256969 (4) [back to overview]Corneal Fluorescein Staining (CFS)
NCT02256969 (4) [back to overview]Tear Break Up Time (TBUT)
NCT02256969 (4) [back to overview]Symptom Assessment in Dry Eye (SANDE)
NCT02260934 (15) [back to overview]Percentage of Participants With an Overall Response at Week 24, Week 48, and Week 96
NCT02260934 (15) [back to overview]Percentage of Participants With At Least One Grade 3 or Higher Infectious Adverse Event By Week 24, Week 48 and Week 96
NCT02260934 (15) [back to overview]Percentage of Participants With B Cell Reconstitution at Week 24, Week 48 and Week 96
NCT02260934 (15) [back to overview]Percentage of Participants With Grade 4 Hypogammaglobulinemia by Week 24, Week 48, and Week 96
NCT02260934 (15) [back to overview]Percentage of Participants Hypocomplementemic for Complement Component C4 at Week 24, Week 48, and Week 96
NCT02260934 (15) [back to overview]Percentage of Participants With Treatment Failure by Week 24, Week 48, and Week 96
NCT02260934 (15) [back to overview]Percentage of Participants With a Sustained Complete Response
NCT02260934 (15) [back to overview]Count of Participants: Frequency of Non-renal Flares by Week 24
NCT02260934 (15) [back to overview]Count of Participants: Frequency of Non-renal Flares by Week 48
NCT02260934 (15) [back to overview]Count of Participants: Frequency of Non-renal Flares by Week 96
NCT02260934 (15) [back to overview]Frequency of Specific Adverse Events of Interest By Event by Week 96
NCT02260934 (15) [back to overview]Frequency of Specific Adverse Events of Interest By Participant, By Week 96
NCT02260934 (15) [back to overview]Percentage of Participants Hypocomplementemic for Complement Component C3 at Week 24, Week 48, and Week 96
NCT02260934 (15) [back to overview]Percentage of Participants With a Complete Response at Week 24, Week 48, and Week 96
NCT02260934 (15) [back to overview]Percentage of Participants With an Negative Anti-dsDNA Result at Week 24, Week 48, and Week 96
NCT02296346 (1) [back to overview]Multiple Sclerosis Functional Composite (MSFC) Z-score and Expanded Disability Status Scale (EDSS)
NCT02406209 (1) [back to overview]Anterior Chamber Cell Grade at Week 8
NCT02464657 (4) [back to overview]Event-Free Survival (EFS)
NCT02464657 (4) [back to overview]Relapse Free Survival
NCT02464657 (4) [back to overview]Maximum Tolerated Dose (MTD) of Nivolumab
NCT02464657 (4) [back to overview]Overall Survival
NCT02515045 (3) [back to overview]Change From Baseline (Preoperative Exam) in Macular Thickness
NCT02515045 (3) [back to overview]Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP)
NCT02515045 (3) [back to overview]Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness)
NCT02539394 (19) [back to overview]Degree of Dysphagia Patients Experience (Social)
NCT02539394 (19) [back to overview]Patients' Bazaz Dysphagia Score - Liquid
NCT02539394 (19) [back to overview]Patients' Pain Scores on the Visual Analog Scale - Right Arm Pain
NCT02539394 (19) [back to overview]Degree of Dysphagia Patients Experience (Sleep)
NCT02539394 (19) [back to overview]Patients' Pain Scores on the Visual Analog Scale - Neck Pain
NCT02539394 (19) [back to overview]Patients' Pain Scores on the Visual Analog Scale - Left Arm Pain
NCT02539394 (19) [back to overview]Patients' Neck Disability
NCT02539394 (19) [back to overview]Patient Reported Swallowing Difficulty Over 1 Year
NCT02539394 (19) [back to overview]Degree of Dysphagia Patients Experience (Mental)
NCT02539394 (19) [back to overview]Degree of Dysphagia Patients Experience (Food Selection)
NCT02539394 (19) [back to overview]Fusion Rate
NCT02539394 (19) [back to overview]Adverse Event
NCT02539394 (19) [back to overview]Degree of Dysphagia Patients Experience (Burden)
NCT02539394 (19) [back to overview]Degree of Dysphagia Patients Experience (Communication)
NCT02539394 (19) [back to overview]Degree of Dysphagia Patients Experience (Eating Desire)
NCT02539394 (19) [back to overview]Degree of Dysphagia Patients Experience (Eating Duration)
NCT02539394 (19) [back to overview]Degree of Dysphagia Patients Experience (Fatigue)
NCT02539394 (19) [back to overview]Patients' Bazaz Dysphagia Score - Solid
NCT02539394 (19) [back to overview]Degree of Dysphagia Patients Experience (Fear Swallow)
NCT02569437 (5) [back to overview]Endoscopic Nasal Polyp Score
NCT02569437 (5) [back to overview]Subjective Symptom Composite Scoring
NCT02569437 (5) [back to overview]Middle Meatus Culture
NCT02569437 (5) [back to overview]Sino-nasal Outcome Test (SNOT 22)
NCT02569437 (5) [back to overview]Visual Analog Scale
NCT02576249 (3) [back to overview]The Knee Osteoarthritis Outcome Score (KOOS) Pain Subscale
NCT02576249 (3) [back to overview]Pain Scale Score
NCT02576249 (3) [back to overview]Tegner Activity Level Scale
NCT02652390 (6) [back to overview]Symptom Severity Score
NCT02652390 (6) [back to overview]Satisfaction Score
NCT02652390 (6) [back to overview]Palmar Pain Score
NCT02652390 (6) [back to overview]Number of Patients Who Have Had Carpal Tunnel Release Surgery on the Study Hand
NCT02652390 (6) [back to overview]Bodily Pain Score
NCT02652390 (6) [back to overview]11-item Disabilities of the Arm, Shoulder and Hand (DASH) Score
NCT02790788 (22) [back to overview]Organ Failure-free Days.
NCT02790788 (22) [back to overview]Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring.
NCT02790788 (22) [back to overview]Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port.
NCT02790788 (22) [back to overview]Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port.
NCT02790788 (22) [back to overview]Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port (as Feasible).
NCT02790788 (22) [back to overview]Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.
NCT02790788 (22) [back to overview]Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.
NCT02790788 (22) [back to overview]Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.
NCT02790788 (22) [back to overview]Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.
NCT02790788 (22) [back to overview]Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring.
NCT02790788 (22) [back to overview]Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring (as Feasible).
NCT02790788 (22) [back to overview]Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring (as Feasible).
NCT02790788 (22) [back to overview]Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port.
NCT02790788 (22) [back to overview]Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring.
NCT02790788 (22) [back to overview]Left and Right Ventricular Diastolic Area (cm^2) by Echocardiography.
NCT02790788 (22) [back to overview]Eccentricity Index by Echocardiography.
NCT02790788 (22) [back to overview]Early Postresuscitation Inflammatory Response as Assessed by Serum Cytokine Levels (pg/mL).
NCT02790788 (22) [back to overview]Core Body Temperature in Degrees Celcius.
NCT02790788 (22) [back to overview]Cerebral Blood Flow Index by Near Infrared Spectroscopy With Indocyanine Green.
NCT02790788 (22) [back to overview]Survival to Hospital Discharge With Favorable Functional Outcome.
NCT02790788 (22) [back to overview]Steroid-associated Complications.
NCT02790788 (22) [back to overview]Left and Right Ventricular Ejection Fraction (%) by Echocardiography.
NCT02798523 (1) [back to overview]Number of Participants Sampled for RNA-seq Differential Expression Analysis (Biological Replicates)
NCT02828358 (5) [back to overview]Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 5 of First Course of Azacitidine
NCT02828358 (5) [back to overview]Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 1 Prior to First Course of Azacitidine
NCT02828358 (5) [back to overview]Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 1 Prior to Second Course of Azacitidine
NCT02828358 (5) [back to overview]Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 5 of Second Course of Azacitidine
NCT02828358 (5) [back to overview]Tolerability of Azacitidine in Combination With Interfant-06 Standard Chemotherapy in Evaluable Infant Patients With Newly Diagnosed ALL With KMT2A Gene Rearrangement (KMT2A-R). KMT2A Gene Rearrangement (KMT2A-R)
NCT02847494 (3) [back to overview]Headache Days as Self-reported by Participants
NCT02847494 (3) [back to overview]Medication Preference as Assessed by Self-report
NCT02847494 (3) [back to overview]Number of Participants With Sustained Headache Freedom
NCT02953678 (10) [back to overview]Overall Response Rate (ORR)
NCT02953678 (10) [back to overview]Number of Participants With Treatment-emergent Adverse Events (TEAES), Serious TEAEs, And Grade 3 or Higher TEAEs
NCT02953678 (10) [back to overview]Relapse-related Mortality Rate
NCT02953678 (10) [back to overview]Relapse Rate
NCT02953678 (10) [back to overview]Percentage of Participants With Three-month DOR
NCT02953678 (10) [back to overview]Overall Survival (OS)
NCT02953678 (10) [back to overview]Failure-free Survival (FFS)
NCT02953678 (10) [back to overview]Overall Response Rate (ORR) at Day 28
NCT02953678 (10) [back to overview]Percentage of Participants With Six-month Duration of Response (DOR)
NCT02953678 (10) [back to overview]Nonrelapse Mortality (NRM)
NCT02956122 (22) [back to overview]Systemic Clearance at Steady State (CLss) of GLASSIA
NCT02956122 (22) [back to overview]"Area Under the Plasma Concentration Curve From Time Zero to Time t AUC(0-t) of GLASSIA"
NCT02956122 (22) [back to overview]Percentage of Participants Achieving Overall Response at Day 56
NCT02956122 (22) [back to overview]Failure-free Survival - Percentage of Participants With an Event
NCT02956122 (22) [back to overview]Graft-versus-host Disease (GvHD)-Free Survival - Percentage of Participants With an Event
NCT02956122 (22) [back to overview]Graft-versus-host Disease (GvHD)-Related Mortality - Percentage of Participants With an Event
NCT02956122 (22) [back to overview]Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
NCT02956122 (22) [back to overview]Transplant-related Mortality
NCT02956122 (22) [back to overview]Overall Survival (OS) - Percentage of Participants With an Event
NCT02956122 (22) [back to overview]Number of Participants With Adverse Events (AEs), Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs and Temporally-associated AEs
NCT02956122 (22) [back to overview]Incidence of Chronic Graft-versus-host Disease (GvHD)
NCT02956122 (22) [back to overview]Infection-related Mortality - Percentage of Participants With an Event
NCT02956122 (22) [back to overview]All-cause Mortality - Percentage of Participants With an Event
NCT02956122 (22) [back to overview]Percentage of Participants Achieving Overall Response (OR) At Day 28
NCT02956122 (22) [back to overview]Number of Participants With Recurrence of Primary Malignancies
NCT02956122 (22) [back to overview]Number of Participants With Clinically Significant Changes in Vital Signs
NCT02956122 (22) [back to overview]Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments
NCT02956122 (22) [back to overview]Maximum Observed Plasma Concentration (Cmax) of GLASSIA
NCT02956122 (22) [back to overview]Area Under the Plasma Concentration Curve (AUC0-inf) From Time Zero to Infinity
NCT02956122 (22) [back to overview]Apparent Volume of Distribution at Steady State (Vss) of GLASSIA
NCT02956122 (22) [back to overview]Apparent Terminal Half-life (t1/2) of GLASSIA
NCT02956122 (22) [back to overview]Percentage of Participants Achieving Gastrointestinal (GI) Response at Day 28
NCT02962284 (6) [back to overview]Percentage of Subjects With Prostate Specific Antigen - 50 Response
NCT02962284 (6) [back to overview]Testosterone Levels
NCT02962284 (6) [back to overview]Testosterone Complete Suppression
NCT02962284 (6) [back to overview]Prostate Specific Antigen Levels
NCT02962284 (6) [back to overview]Number of Subjects With Adverse Events
NCT02962284 (6) [back to overview]Proportion of Subjects With Disease Progression
NCT03123614 (4) [back to overview]Uncorrected Visual Acuity
NCT03123614 (4) [back to overview]Change in Intraocular Pressure (IOP) From Baseline Through Month 3
NCT03123614 (4) [back to overview]Best Corrected Visual Acuity at 3 Months
NCT03123614 (4) [back to overview]Number of Eyes With Corneal Haze
NCT03139604 (20) [back to overview]Cmax of Itacitinib When Administered in Combination With Corticosteroids
NCT03139604 (20) [back to overview]Cmin of Itacitinib When Administered in Combination With Corticosteroids
NCT03139604 (20) [back to overview]Duration of Response
NCT03139604 (20) [back to overview]Failure-free Survival
NCT03139604 (20) [back to overview]Incidence Rate of Secondary Graft Failure
NCT03139604 (20) [back to overview]Malignancy Relapse-related Mortality Rate
NCT03139604 (20) [back to overview]Number of Treatment-emergent Adverse Events With INCB39110
NCT03139604 (20) [back to overview]Incidence Rate of aGVHD Flares
NCT03139604 (20) [back to overview]Overall Response Rate Based on Center for International Blood and Marrow Transplant Research (CIBMTR) Response Index
NCT03139604 (20) [back to overview]Overall Survival (OS)
NCT03139604 (20) [back to overview]Relapse Rate of Malignant and Nonmalignant Hematologic Disease
NCT03139604 (20) [back to overview]Time to Response
NCT03139604 (20) [back to overview]Tmax of Itacitinib When Administered in Combination With Corticosteroids
NCT03139604 (20) [back to overview]Incidence Rate of cGVHD
NCT03139604 (20) [back to overview]Nonrelapse Mortality
NCT03139604 (20) [back to overview]Objective Response Rate
NCT03139604 (20) [back to overview]Proportion of Subjects Who Discontinue Corticosteroids
NCT03139604 (20) [back to overview]Proportion of Subjects Who Discontinue Immunosuppressive Medications
NCT03139604 (20) [back to overview]CL/F of Itacitinib When Administered in Combination With Corticosteroids
NCT03139604 (20) [back to overview]AUC of Itacitinib When Administered in Combination With Corticosteroids
NCT03229538 (7) [back to overview]Number of Participants With Prolonged Mechanical Ventilation (Greater Than 7 Days)
NCT03229538 (7) [back to overview]Number of Participants With a Post-operative Length of Stay Greater Than 90 Days
NCT03229538 (7) [back to overview]Number of Participants With Any Other Post-operative Complications From the Start of Study Drug Administration Until Hospital Discharge.
NCT03229538 (7) [back to overview]Number of Participants With Death or Major Complication as Defined by an Outcome in One of the 7 Highest Global Ranking Categories
NCT03229538 (7) [back to overview]Number of Participants With Mortality, Including In-hospital Mortality or Mortality After Hospital Discharge But Within 30 Days of the Last Dose of Study Drug
NCT03229538 (7) [back to overview]Number of Participants With Occurrence of Any One or More of the Following STS-CHSD-defined Major Post-operative Infectious Complications: Postprocedural Infective Endocarditis, Pneumonia, Sepsis, Deep Wound Infection, Mediastinitis.
NCT03229538 (7) [back to overview]Number of Participants With Post-operative Low Cardiac Output Syndrome
NCT03320434 (4) [back to overview]Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1
NCT03320434 (4) [back to overview]Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1
NCT03320434 (4) [back to overview]Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 15
NCT03320434 (4) [back to overview]Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 15
NCT03387046 (16) [back to overview]Symbol Digit Modalities Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
NCT03387046 (16) [back to overview]Symbol Digit Modalities Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
NCT03387046 (16) [back to overview]Number of Participants With Change From Baseline in Multiple Sclerosis Related Disability Measured by Expanded Disability Status Scale (EDSS) at Week 12 and 24
NCT03387046 (16) [back to overview]Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24
NCT03387046 (16) [back to overview]Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
NCT03387046 (16) [back to overview]Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
NCT03387046 (16) [back to overview]Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)
NCT03387046 (16) [back to overview]Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)
NCT03387046 (16) [back to overview]Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24
NCT03387046 (16) [back to overview]Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24
NCT03387046 (16) [back to overview]9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
NCT03387046 (16) [back to overview]9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
NCT03387046 (16) [back to overview]25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
NCT03387046 (16) [back to overview]Number of Participants With Change From Baseline in Multiple Sclerosis Related Disability Measured by Expanded Disability Status Scale (EDSS) at Week 8
NCT03387046 (16) [back to overview]Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24
NCT03387046 (16) [back to overview]25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
NCT03403517 (5) [back to overview]Hospital Stay
NCT03403517 (5) [back to overview]Complications, Post-anesthesia Care Unit (PACU)
NCT03403517 (5) [back to overview]Mortality
NCT03403517 (5) [back to overview]PACU Stay
NCT03403517 (5) [back to overview]Total Complication Rate
NCT03578276 (3) [back to overview]Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP)
NCT03578276 (3) [back to overview]Change From Baseline (Preoperative Exam) in Macular Thickness
NCT03578276 (3) [back to overview]Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness)
NCT03593902 (2) [back to overview]Change in Skin Score by mRSS
NCT03593902 (2) [back to overview]Survival of Treatment
NCT03704584 (3) [back to overview]Visual Analog Pain Scale (VAS-pain) Daily Until Post-injection Day 7
NCT03704584 (3) [back to overview]10 Point Likert Scale of Pain Scores Before the Injection and After the Injection and During Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group
NCT03704584 (3) [back to overview]Number of Patients With Subsequent Reinjection and Surgical Operation
NCT03797872 (1) [back to overview]Number of Participants Who Are Eligible, Consent, and Complete the 48 Weeks Study
NCT03852537 (14) [back to overview]Occurrence of Hyperglycemia
NCT03852537 (14) [back to overview]Occurrence of Secondary Infection
NCT03852537 (14) [back to overview]Oxygen-free Days
NCT03852537 (14) [back to overview]Timely Initiation of Corticosteroids and Implementation of Biomarker-titrated Corticosteroid Dosing
NCT03852537 (14) [back to overview]Organ Failure
NCT03852537 (14) [back to overview]ICU Admission
NCT03852537 (14) [back to overview]Cardiovascular Dysfunction
NCT03852537 (14) [back to overview]Mortality
NCT03852537 (14) [back to overview]Myocardial Injury
NCT03852537 (14) [back to overview]Need for High Flow Nasal Cannula Oxygen
NCT03852537 (14) [back to overview]Need for Invasive Mechanical Ventilation
NCT03852537 (14) [back to overview]Need for Noninvasive Mechanical Ventilation
NCT03852537 (14) [back to overview]New Onset Cardiac Arrhythmias
NCT03852537 (14) [back to overview]Occurrence of Delirium
NCT04046549 (7) [back to overview]Percentage of Participants With Biopsy Proven Acute Rejection (BPAR)
NCT04046549 (7) [back to overview]Percentage of Participants With Antibody-Mediated Rejection
NCT04046549 (7) [back to overview]Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR), Graft Loss, Death or Loss to Follow-up (LTFU)
NCT04046549 (7) [back to overview]Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR) of Grade 1A or Higher, Graft Loss or Death at Weeks 12 and 48
NCT04046549 (7) [back to overview]Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR)
NCT04046549 (7) [back to overview]Percentage of Participants With Treated Acute Rejections
NCT04046549 (7) [back to overview]Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR) of Grade 1A or Higher, Graft Loss or Death at Week 24
NCT04184999 (1) [back to overview]Evaluation of Intraoperative Use of Dexycu on Tear Film Osmolarity at 3 Weeks Postoperatively
NCT04233164 (1) [back to overview]Number of SLE Patients That Were Sampled for RNA-seq Differential Expression Analysis (Biological Replicates)
NCT04323592 (6) [back to overview]Endotracheal Intubation (Invasive Mechanical Ventilation)
NCT04323592 (6) [back to overview]In-hospital Death Within 28 Days
NCT04323592 (6) [back to overview]Number of Days Free From Mechanical Ventilation
NCT04323592 (6) [back to overview]Admission to Intensive Care Unit (ICU)
NCT04323592 (6) [back to overview]Change in C-reactive Protein (CRP)
NCT04323592 (6) [back to overview]Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation (MV), or All-cause Death by Day 28
NCT04380857 (5) [back to overview]Number of Lines Lost From Best Corrected Visual Acuity
NCT04380857 (5) [back to overview]Patient Preference Between Groups
NCT04380857 (5) [back to overview]Loss of Lines in Uncorrected Visual Acuity
NCT04380857 (5) [back to overview]Mean Change in Pain
NCT04380857 (5) [back to overview]Post op Pain Management Per Eye
NCT04900220 (2) [back to overview]Intensity of Pain
NCT04900220 (2) [back to overview]Incidence of Pain
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Overall Assessment of Knee After Surgery and Treatment
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Overall Assessment of Knee After Surgery and Treatment
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Overall Assessment of Knee Before Treatment
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Overall Assessment of Knee Before Treatment
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Overall Assessment of Knee Prior to Treatment
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Overall Assessment of Knee Prior to Treatment
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Post Treatment Pain Scores
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Post Treatment Pain Scores
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Pre Treatment Pain Scores Using Knee Society Scores
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Post Treatment Pain Scores (6 Weeks)
NCT05113901 (18) [back to overview]Adverse Events or Outcomes Outside of Manipulations Under Anesthesia
NCT05113901 (18) [back to overview]Number of Participants With Complications Following Treatment
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Overall Assessment of Knee 6 Weeks After Treatment
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Overall Assessment of Knee 6 Weeks After Treatment
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Overall Assessment of Knee 6 Weeks After Treatment
NCT05113901 (18) [back to overview]Range of Motion in Degrees at Pre and Post Treatment
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures:(Immediate) Post Treatment Pain Scores
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Overall Assessment of Knee 6 Wks After Treatment

Toxic Death

Implementation of the toxic death rate stopping rule, a death must be possibly, probably or definitely attributable to Rituximab and/or chemotherapy to be considered a toxic death. (NCT00057811)
Timeframe: Up to 1 year

,
Interventionparticipants (Number)
Toxic deathNo toxic death
Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)045
Group C (Chemotherapy, Monoclonal Antibody Therapy)238

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Grade ≥ 3 Stomatitis

The incidence of grade ≥ 3 stomatitis. Grade 3 stomatitis: Confluent ulcerations or pseudomembranes; bleeding with minor trauma. Grade 4 stomatitis: Tissue necrosis; Significant spontaneous bleeding; life-threatening consequences (NCT00057811)
Timeframe: Up to 1 year

,
Interventionparticipants (Number)
Incidence of grade ≥ 3 stomatitisNo incidence of grade ≥ 3 stomatitis
Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)441
Group C (Chemotherapy, Monoclonal Antibody Therapy)634

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Response Rate

Response includes both complete and partial responses. Per protocol, complete Response is defined as the complete disappearance of all clinical evidence of disease by physical examination, by imaging studies, by bone marrow biopsy (where indicated), by CNS evaluation (where indicated) and by biopsy where there is a residual abnormality on an imaging study. Bone marrow must contain <5% blasts. CSF WBC must be <5/μL with no blasts or lymphomatous cells present. Partial response is defined as: at least a 50% reduction in the size of all measurable tumor areas. Each site is to be defined by the product of the maximum length, width and depth (3 dimensions). No lesion may progress. No new lesion may appear. Bone marrow must contain <5% blasts. CSF WBC must be <5/μL with no blasts or lymphomatous cells present.. (NCT00057811)
Timeframe: Up to 5 years

Interventionpercentage of participants analyzed (Number)
Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)88
Group C (Chemotherapy, Monoclonal Antibody Therapy)83

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Minimal Residual Disease

The presence or absence of tumor cells at the end of induction assessed by studying tissue and/or blood/marrow. Details of methods and criteria used can be found in Shiramizu at al. BJH 153:758-763, 2011 (full citation in the citation section). (NCT00057811)
Timeframe: Not Provided

Interventionpercentage of samples analyzed (Number)
Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)22
Group C (Chemotherapy, Monoclonal Antibody Therapy)70

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Event-free Survival

Alive in continuous complete remission with functioning original allograft. The Event Free Survival (EFS) will be estimated by the Kaplan-Meier method. (NCT00066469)
Timeframe: 2 years

Interventionpercentage of participants analyzed (Number)
Cyclophosphamide, Prednisone, Rituximab71

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Hearing Improvement

Change from baseline to 2mos of 4-frequency (500, 1000, 2000, 4000Hz) pure tone average. (NCT00097448)
Timeframe: 2 months

InterventiondB (Mean)
Oral Steroids30.7
IT Steroids28.7

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2-year Overall Survival Rate

The overall survival rate is the percentage of patients who are alive 2 years after registration to the study. Overall survival is defined as the time between study registration and death due to any cause. (NCT00109928)
Timeframe: 0-2 years

Interventionpercentage of participants (Number)
PEGS31

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Response Rate

Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. (NCT00109928)
Timeframe: up to 3 years or time of disease progression

Interventionparticipants (Number)
Complete ResponseUnconfirmed Complete ResponsePartial ResponseNo Response
PEGS62520

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2-year Progression-free Survival Rate

Progression-free survival rate is the percentage of patients who do not show signs of progression at 2 years after registration to the study, including those whose disease has either completely or partially responded to treatment, or those whose disease is stable. Progression-free survival is defined as the time between study registration and documented progression, or death if no progression was observed. (NCT00109928)
Timeframe: 0-2 years

Interventionpercentage of participants (Number)
PEGS12

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Length of Time on a Ventilator

(NCT00128180)
Timeframe: 6 months

Interventiondays (Mean)
Active2.64
Placebo4.95

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Duration of Shock and/or Pressor/Inotropic Support

Pressor/inotropic support refers to the use of adrenaline-like medications to maintain blood pressure and cardiac output. (NCT00128180)
Timeframe: 6 months

Interventiondays (Mean)
Active2.67
Placebo3.75

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Duration of Hospital Stay in Days

Days (NCT00128180)
Timeframe: 6 months

Interventiondays (Mean)
Active8.90
Placebo10.67

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Development of Serum Creatinine Greater Than or Equal to 3.0 mg/dL After Study Entry

(NCT00128180)
Timeframe: 6 months

Interventionparticipants (Number)
Active1
Placebo6

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Number of Participants Who Developed Refractory Shock Despite Fluid Resuscitation After Study Entry

Refractory shock refers to shock that persists despite fluid resucitation. Fluid resusitation refers to administration of intravenous fluids to maintain blood pressure and cardiac output. (NCT00128180)
Timeframe: 6 months

Interventionparticipants (Number)
Active4
Placebo6

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Number of Participants on Extracorporeal Membrane Oxygenation (ECMO)

number of participants (NCT00128180)
Timeframe: 6 months

Interventionparticipants (Number)
Active0
Placebo0

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The Proportion of Subjects Who Develop Death, PaO2/FiO2 Ratio Less Than or Equal to 55, Cardiac Index Less Than or Equal to 2.2, Pulseless Electrical Activity, Ventricular Tachycardia or Fibrillation

(NCT00128180)
Timeframe: 28 days

Interventionproportion of paticipants (Number)
Active0.27
Placebo0.47

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Duration of ICU Stays

(NCT00128180)
Timeframe: 6 months

Interventiondays (Mean)
Active4.48
Placebo5.83

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Number of Participants With SAEs

The Number of participants with SAEs (NCT00128180)
Timeframe: 6 months

Interventionparticipants (Number)
Active14
Placebo25

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Number of Participants Intubated and Placed on a Ventilator After Study Entry.

Participants (NCT00128180)
Timeframe: 6 months

Interventionparticipants (Number)
Active6
Placebo10

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Engraftment of Haploidentical CD34+ Selected Blood Stem Cells in Older Patients or Those With Medical Co-morbidities Following Total Lymphoid Irradiation and Antithymocyte Globulin Transplant Conditioning

number achieving donor cell engraftment (>95%) by day 90 after transplant. (NCT00185692)
Timeframe: 100 days

InterventionParticipants (Count of Participants)
Transplantation of CD34+ Cells4

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Acute Graft-versus-Host Disease (GVHD) Grade 2-4 Risk From Time of Transplant Until Day 90 Post-transplant

GVHD grading system goes from 0-4 where grade 4 is the most severe. Grade 0 and 1 do not require systemic treatment, Grade 2-4 require treatment. This trial evaluated the risk of developing acute GVHD grades 2-4 within 90 days of transplant. (NCT00185692)
Timeframe: 90 days

InterventionParticipants (Count of Participants)
Transplantation of CD34+ Cells1

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Chronic Graft-vs-Host Disease (cGvHD)

The cumulative percentage of participants who develop chronic graft-vs-host disease (cGvHD). Chronic cGvHD was defined as at least one instance of a clinically-accepted marker for cGvHD (see Filipovich, et al. Biology of Blood and Marrow Transplantation. 2005;11:945-955) (NCT00186628)
Timeframe: 4 years

Interventionpercentage of participants (Number)
Prophylactic Rituximab20

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Incidence of Relapse

Subjects who Relapsed following after Allogeneic HSCT (NCT00186628)
Timeframe: 4 years

InterventionParticipants (Count of Participants)
Prophylactic Rituximab18

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Overall Survival

(NCT00186628)
Timeframe: 4 years

InterventionPercentage of participants by disease (Number)
Prophylactic Rituximab (CLL Patients)73
Prophylactic Rituximab (MCL Patients)69

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Mortality

Number of participants who died within 100 days and within 1 year, non-relapse and associated with relapse. (NCT00186628)
Timeframe: Day 100 and 1 year

InterventionParticipants (Number)
Mortality within 100 days, all causesNonrelapse mortality within 1 yearRelapse + mortality within 1 year
Prophylactic Rituximab012

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1 Year Overall Survival Rate

(NCT00248534)
Timeframe: 1 year

Interventionpercentage of participants (Number)
IV Rituximab71

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6-month Progression-free Survival

"Scan at 6 months~Complete response: Complete disappearance of all tumor on MRI scan, off all glucocorticoids with stable or improving neurological exam minimum of 4 wks~Partial response: Greater than or equal 50% reduction in tumor size on MRI, on sable or decreasing glucocorticoids with stable or improving neurological exam for a minimum of 4 wks.~Progressive disease: Progressive neurological abnormalities not explained by other causes or greater than 25% increase in size of tumor or if new lesion.~Stable disease: Clinical status and MRI does not qualify for complete response, partial response or progression" (NCT00248534)
Timeframe: 6 months

Interventionpercentage of participants (Number)
IV Rituximab13

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Number of Participants Alive at 3 Years

The intent was to measure Median Overall Survival at 3 years, however only one participant was analyzable at this time point. Therefore, the number of participants who survived is reported instead. (NCT00248534)
Timeframe: 3 years

InterventionParticipants (Count of Participants)
IV Rituximab1

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Percentage of Participants With Objective Response

Objective response rate of the combination of Rituximab and TMZ (NCT00248534)
Timeframe: 2 months

Interventionpercent of participants (Number)
IV Rituximab14

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Time Measured From the Administration of the Loading Dose of Prednisolone (2mg/kg up to Max 60mg) in the Emergency Department (ED) Until the Home Dose of Albuterol is Administered

(NCT00257933)
Timeframe: Median time from loading dose to home dose of albuterol

InterventionHours (Median)
High Dose Prednisolone35
Lower Dose Prednisolone33

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Survival

Survival (NCT00278564)
Timeframe: up to 5 years

InterventionParticipants (Count of Participants)
Hematopoietic Stem Cell Transplantation7

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Numerical Rating Scale (0-10), an Interval Pain Scale, on Which 0 Indicates no Pain and 10 Indicates the Worst Pain Imaginable

Improvement in Numerical Rating Scale between the time of the emergency department visit and the one month telephone call is rated on an 11-point scale ranging from 0-10 with 0 indicating no pain and 10 indicating worse pain imaginable. (NCT00290589)
Timeframe: 1 month

Interventionunits on a scale (Mean)
Intramuscular Methylprednisolone Acetate7.1
Placebo5.8

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Functional Disability Scales

The low back pain functional disability scale is the Roland Morris Disability questionnaire score (RMDQ). The RMDQ is a 24-item low back pain functional scale recommended for use in low back pain research.Higher scores signify greater low back-related functional impairment.0= no functional impairment, 24= severe functional impairment. (NCT00290589)
Timeframe: 1 month

Interventionunits on a scale (Median)
Intramuscular Methylprednisolone Acetate0
Placebo0

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Number of Patients Using Analgesics

Use of analgesics for low back pain (within the previous 24 hours) (NCT00290589)
Timeframe: Assessed at 1 month

InterventionParticipants (Count of Participants)
Intramuscular Methylprednisolone Acetate8
Placebo17

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C-reactive Protein Levels

Estimated mean and standard deviation (NCT00309907)
Timeframe: From baseline to days 7, 14, 21, and 28

Interventionmg/dL (Mean)
BaselineDay 7 Non RespondersDay 7 RespondersDay 14 Non RespondersDay 14 RespondersDay 21 Non RespondersDay 21 RespondersDay 28 Non RespondersDay 28 Responders
Etanercept and Corticosteroid Therapy28.15.41.84.9110.71.619.65.3

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Survival Rate

Estimated Day 56 survival rate following initiation of etanercept + corticosteroid therapy for patients with IPS. (NCT00309907)
Timeframe: Up to day 56

Interventionpercentage of participants (Number)
Etanercept and Corticosteroid Therapy75

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Response of IPS (Idiopathic Pneumonia Syndrome) to Etanercept Plus Corticosteroid Therapy by Day 28.

Response to therapy is defined as survival to Day 28 of study, PLUS complete discontinuation all supplemental oxygen support by Day 28 of study. Subjects must be able to remain off all supplemental oxygen support for > 72 consecutive hours. Subjects who discontinue supplemental oxygen within the last 72 hours of the observation period will be followed until they have completed 72 consecutive hours off oxygen or failed prior to assessing response. (NCT00309907)
Timeframe: At day 28

Interventionparticipants (Number)
With ResponseWithout Response
Etanercept and Corticosteroid Therapy208

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Plasma Cytokine IL6 Level

Estimated mean and standard error of IL6 level (NCT00309907)
Timeframe: From baseline to days 7 and 28

Interventionpg/ml (Mean)
BaselineDay 7Day 28
Etanercept and Corticosteroid Therapy205.228.823.1

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Estimate Percentage Pulmonary Response in Patients With IPS Treated With Etanercept + Corticosteroid Therapy

Pulmonary response is defined as alive & come off of oxygen . (NCT00309907)
Timeframe: up to day 56

Interventionpercentage of participants (Number)
Etanercept and Corticosteroid Therapy74

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Toxicity of Etanercept Plus Corticosteroid Therapy Using the Common Terminology Criteria Version 4.0

Grade 3-5 organ toxicities attributable to etanercept. (NCT00309907)
Timeframe: Up to 56 days

InterventionPatients (Number)
Etanercept and Corticosteroid Therapy0

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Number of Vomiting Episodes Per Day at Day1, Day 2 and Day 14

The mean number of vomiting episodes per a 24 hour period is presented for Day 1, Day 7 and Day 14. (NCT00332696)
Timeframe: Day 1, Day 7 and Day 14

,
InterventionVomiting episodes (Mean)
Day 1Day 7 (n=31,31)Day 14 (n=28,27)
Octreotide1.20.30.3
Placebo0.60.40.5

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Participant's Quality of Life Using the Edmonton Scale

The Edmonton Scale consisted of 9 items: pain, activity, nausea, depression, anxiety, fatigue, appetite, sensation of well-being and dyspnea (difficult or labored breathing). Participants rated these items on a scale of 0 to 10, with 10 being the worse. (NCT00332696)
Timeframe: Day 1, Day 7, Day 14, Month 1, Month 2 and Month 3

,
InterventionScores on a scale (Mean)
Day 1 (n=30,29)Day 7 (n=24,26)Day 14 (n=20,14)Month 1 (n=11,13)Month 2 (n=7,4)Month 3 (n=2,2)
Octreotide4.124.234.304.183.460.05
Placebo4.123.373.854.493.231.60

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Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 1

Recurrence of bowel obstruction was confirmed by abdominal X-ray. (NCT00332696)
Timeframe: 1 Month

,
InterventionParticipants (Number)
Recurrence at Month 1No Recurrence at Month 1
Octreotide113
Placebo213

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Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7

Participants rated their nausea intensity on a scale of 0 to 3, with 3 being the worse. The number of participants with a score of 0, a score of 1, a score of 2 and a score of 3 are presented for Day 7. (NCT00332696)
Timeframe: Day 7

,
InterventionParticipants (Number)
Score=0Score=1Score=2Score=3
Octreotide21253
Placebo15961

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Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1

Participants rated their nausea intensity on a scale of 0 to 3, with 3 being the worse. The number of participants with a score of 0, a score of 1, a score of 2 and a score of 3 are presented for Day 1. (NCT00332696)
Timeframe: Day 1

,
InterventionParticipants (Number)
Score=0Score=1Score=2Score=3
Octreotide16178
Placebo13298

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Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14

Participants rated their nausea intensity on a scale of 0 to 3, with 3 being the worse. The number of participants with a score of 0, a score of 1, a score of 2 and a score of 3 are presented for Day 14. (NCT00332696)
Timeframe: Day 14

,
InterventionParticipants (Number)
Score=0Score=1Score=2Score=3
Octreotide22222
Placebo22311

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Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 2

Recurrence of bowel obstruction was confirmed by abdominal X-ray. (NCT00332696)
Timeframe: Month 2

,
InterventionParticipants (Number)
Recurrence at Month 2No Recurrence at Month 2
Octreotide26
Placebo25

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Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 3

Recurrence of bowel obstruction was confirmed by abdominal X-ray. (NCT00332696)
Timeframe: Month 3

,
InterventionParticipants (Number)
Recurrence at Month 3No Recurrence at Month 3
Octreotide03
Placebo02

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Number of Participants With Relief From Obstruction at Day 7 and Day 14

Relief from obstruction is defined by combining restart of stools for at least the previous 3 days, less than 2 episodes of vomiting on average for the previous 4 days and the restarting of flatus (gas generated in the stomach or bowels) for at least the previous 12 hours. (NCT00332696)
Timeframe: Day 7 and Day 14

,
InterventionParticipants (Number)
Relief from Obstruction: Day 7No Relief from Obstruction: Day 7Relief from Obstruction: Day 14No Relief from Obstruction: Day 14
Octreotide9201110
Placebo1512105

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Number of Participants With Treatment Success From Day 10 to Day 13

"Treatment Success was defined as: less than 2 episodes of vomiting on average per day for the 4 days prior to Day 14 [from Day 10 to Day 13] and no use of an Nasogastric Tube (NGT) since at least Day 10 and no use of an anticholinergic agent until Day 14.~Treatment Failure is defined as: 2 or more episodes of vomiting per day on average for the 4 days prior to Day 14 or use of an NGT after Day 9 or use of an anticholinergic agent before Day 14 or withdrawal from the trial between Day 1 and Day 14 (included), whatever the cause." (NCT00332696)
Timeframe: Day 10 to Day 13

,
InterventionParticipants (Number)
TREATMENT SUCCESSVomiting episodes <2 (per day)Vomiting episodes ≥2 (per day)No Nasogastric Tube since Day 10Nasogastric Tube used since Day 10No Anticholinergic agentsAnticholinergic agents takenPremature discontinuation/missing data, failure
Octreotide1219214718311
Placebo913213211417

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Number of Participants With Treatment Success From Day 5 to Day 7

Day 7 treatment success was defined as improvement of symptoms in the previous 2 days (average number of vomiting episodes less than 2 from Day 5, no Nasogastric Tube (NGT) since Day 5 and no anticholinergic agent or withdrawal from trial). (NCT00332696)
Timeframe: Day 5 to Day 7

,
InterventionParticipants (Number)
TREATMENT SUCCESSVomiting episodes <2 (per day) since Day 5Vomiting episodes ≥2 (per day) since Day 5No Nasogastric Tube since Day 5Nasogastric Tube used since Day 5No Anticholinergic agentsAnticholinergic agents takenPremature discontinuation/missing data
Octreotide222812272633
Placebo202522432525

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Percent Change in Flare at Resolution

(NCT00345046)
Timeframe: 2 months

InterventionPercent change in flare (Mean)
Pred Forte 1%64.8
Econo Pred Plus 1%68.3
Predisolone Acetate 1%65.7

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Number of Participants (Patients) With Chronic Graft-Versus-Host Disease

The chronic form of graft-versus-host-disease (cGVHD) normally occurs after 100 days. The appearance of moderate to severe cases of cGVHD adversely influences long-term survival. (NCT00354172)
Timeframe: Day 100 through 1 Year Post Transplant

InterventionParticipants (Number)
Evaluable Patients1

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Number of Participants (Patients) Who Attained Neutrophil Engraftment

"Defined as absolute neutrophils (ANC) > 5 x 10^8/Liter for 3 consecutive days.~ANC is the real number of white blood cells (WBCs) that are neutrophils. The absolute neutrophil count is commonly called the ANC. The ANC is not measured directly. It is derived by multiplying the WBC count times the percent of neutrophils in the differential WBC count. The percent of neutrophils consists of the segmented (fully mature) neutrophils) + the bands (almost mature neutrophils). The normal range for the ANC = 1.5 to 8.0 (1,500 to 8,000/mm3)." (NCT00354172)
Timeframe: Day 42 Post Transplant

InterventionParticipants (Number)
Evaluable Patients13

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Number of Participants (Patients) Who Attained Platelet Engraftment

Platelet engraftment is defined as platelet counts > 50 x 10^9/Liter for 3 consecutive days. (NCT00354172)
Timeframe: 1 Year Post Transplant

InterventionParticipants (Number)
Evaluable Patients5

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Number of Participants (Patients) Who Died by 12 Months

Number of patients who died after receiving treatment within 12 months post transplant. (NCT00354172)
Timeframe: 1 year Post Transplant

InterventionParticipants (Number)
Evaluable Patients14

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Number of Participants (Patients) Who Died by 24 Months

Number of patients who died after receiving treatment within 24 months post transplant. (NCT00354172)
Timeframe: 2 years post-transplant

InterventionParticipants (Number)
Evaluable Patients15

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Number of Participants (Patients) Who Experienced Relapse by 12 Months

Number of patients who experienced recurrence or progression of disease from the time of transplant. (NCT00354172)
Timeframe: 1 Year Post Transplant

InterventionParticipants (Number)
Evaluable Patients10

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Number of Participants (Patients) With Successful Natural Killer Cell Expansion

Defined by an absolute circulating donor-derived natural killer cell count of >100 cells/microliter 10-13 days after infusion with <5% donor T and B cells in the mononuclear population (NCT00354172)
Timeframe: 10-13 Days Post Infusion

InterventionParticipants (Number)
Evaluable Patients3

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Number of Participants (Patients) Who Were Disease-free and Alive at 6 Months

Number of patients who were alive and free of disease (malignancy) at 6 months after transplant. (NCT00354172)
Timeframe: 6 Months Post Transplant

InterventionParticipants (Number)
Evaluable Patients2

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Number of Participants (Patients) With Acute Graft-versus-host Disease (GVHD) Grade II-IV

Graft-versus-host disease (GVHD) is a common complication of transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. The acute or fulminant form of the disease (aGVHD) is normally observed within the first 100 days post-transplant, and is a major challenge to transplants owing to associated morbidity and mortality. Acute GVHD is staged as follows: overall grade (skin-liver-gut) with each organ staged individually from a low of I to a high of IV. Patients with grade IV GVHD usually have a poor prognosis. (NCT00354172)
Timeframe: Day 100 Post Transplant

InterventionParticipants (Number)
Evaluable Patients6

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Number of Participants (Patients) Who Were Disease-free and Alive at 12 Months

Number of patients who were alive and free of disease (malignancy) at 12 months after transplant. (NCT00354172)
Timeframe: 12 Months Post transplant

InterventionParticipants (Number)
Evaluable Patients1

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Number of Participants (Patients) Who Experienced Relapse by 24 Months

Number of patients who experienced recurrence or progression of disease from the time of transplant. (NCT00354172)
Timeframe: 2 Years Post transplant

InterventionParticipants (Number)
Evaluable Patients11

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Number of Participants (Patients) Who Died Due to Transplant.

Patients who had transplant-related mortality (TRM). TRM = adverse event(s) that occur(s) after the patient has received a transplant, the principal investigator decides it is related to the procedure and the patient dies within 6 months. (NCT00354172)
Timeframe: 6 Months Post Transplant

InterventionParticipants (Number)
Evaluable Patients4

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Number of Patients Who Were Disease-free and Alive at 24 Months

Number of patients who were alive and free of disease (malignancy) at 24 months after transplant. (NCT00354172)
Timeframe: 24 Months Post transplant

InterventionParticipants (Number)
Evaluable Patients0

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Chimerism After Double Umbilical Cord Blood Transplant (UCBT)

Calculation of Median (range) of percentage of donor cells engrafted (present) in the recipient (patient). (NCT00354172)
Timeframe: Day 21, Day 100, 6 Months

InterventionPercentage of Engrafted Cells (Median)
Day 21Day 1006 Months
Evaluable Patients9210096.5

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Number of Participants (Patients) With Acute Graft-versus-Host Disease at Grade III-IV

Graft-versus-host disease (GVHD) is a common complication of transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. The acute or fulminant form of the disease (aGVHD) is normally observed within the first 100 days post-transplant, and is a major challenge to transplants owing to associated morbidity and mortality. Acute GVHD is staged as follows: overall grade (skin-liver-gut) with each organ staged individually from a low of I to a high of IV. Patients with grade IV GVHD usually have a poor prognosis. (NCT00354172)
Timeframe: Day 100 post transplant

InterventionParticipants (Number)
Evaluable Patients1

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Mean Change in Asthma Score at 2 Hours

The scale used is the Asthma Score published by Qureshi et al. The Asthma Score ranges from a low of 5 to maximum of 15 points. One to 3 points are given for each of 5 categories: age-based respiratory rate, oxygen saturation, wheeze, retractions, and dyspnea. For category detalails, please see the Qureshi reference. Scores of 5-7 are considered mild, 8-11 moderate, and 12-15 severe. Asthma Scores are recorded prior to any intervention and at 2 hours after budesonide inhalation suspension/albuterol intervention or saline placebo/albuterol comparator. (NCT00393367)
Timeframe: Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator

InterventionUnits on a scale (Mean)
Budesonide Inhalation Suspension (BIS)-2.9
Placebo (Normal Saline)-3.0

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Change in Mean Heart Rate

Mean of heart rate in beats per minute before treatment minus mean of heart rate 2 hours after treatment with either budesonide/albuterol or saline/albuterol (NCT00393367)
Timeframe: From the initial heart rate to heart rate 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator

InterventionBeats per minute (Mean)
Budesonide Inhalation Suspension (BIS)12
Placebo (Normal Saline)13

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Serious Adverse Events

Serious Adverse Events (NCT00393367)
Timeframe: 0-5 days

,
Interventionparticipants (Number)
Return within 5 days with hosptial admissionIncreased level of care
Budesonide Inhalation Suspension (BIS)21
Placebo (Saline)20

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Number of Participants With Adverse Events (Non-serious).

(NCT00393367)
Timeframe: within 30 days of the ED visit

,
InterventionParticipants (Number)
RhinorrheaHeadacheDiarrheaSore throatCoughHyperglycemia
Budesonide Inhalation Suspension (BIS)653422
Placebo (Normal Saline)1197330

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Relapse / Readmission Numbers.

Participants admitted to the hospital within 5 days of the ED visit (NCT00393367)
Timeframe: within 5 days of ED visit

InterventionParticipants (Number)
Budesonide Inhalation Suspension (BIS)2
Placebo (Normal Saline)2

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Oxygen Saturation.

Mean oxygen saturation (non-invasive pulse-oximetry, % hemoglobin saturation) 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator minus mean oxygen saturation before treatment. (NCT00393367)
Timeframe: 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator

InterventionPercent Hemoglobin Saturation (Mean)
Budesonide Inhalation Suspension (BIS)1.0
Placebo (Normal Saline)1.0

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Number of Subjects Remaining in the Severe Asthma Category

Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who remained in this category 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator. (NCT00393367)
Timeframe: From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator

InterventionParticipants (Number)
Budesonide Inhalation Suspension (BIS)4
Placebo (Normal Saline)4

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Number of Subjects Moving From the Severe Asthma to Mild Asthma Category

Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who moved to the mild category (Asthma Severity score 5-7) 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator. (NCT00393367)
Timeframe: From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator

InterventionParticipants (Number)
Budesonide Inhalation Suspension (BIS)8
Placebo (Normal Saline)10

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Number of Subjects Moving From the Severe Asthma to Moderate Asthma Category

Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who moved to the moderate category (Asthma Severity score 8-11) 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator. (NCT00393367)
Timeframe: From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator

InterventionParticipants (Number)
Budesonide Inhalation Suspension (BIS)22
Placebo (Normal Saline)11

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Number of Patients Hospitalized

The number of patients requiring hospital admission 4 hours after budesonide/albuterol intervention or saline/albuterol comparator. All hospitalization decisions are made at the discretion of the attending physician. (NCT00393367)
Timeframe: within 4 hours after the budesonide/albuterol intervention or saline/albuterol placebo

InterventionParticipants (Number)
Budesonide Inhalation Suspension (BIS)56
Placebo (Saline)55

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Median Change in Asthma Score 2 Hours After Intervention

The scale used is the Asthma Score published by Qureshi et al. The Asthma Score ranges from a low of 5 to maximum of 15 points. One to 3 points are given for each of 5 categories: age-based respiratory rate, oxygen saturation, wheeze, retractions, and dyspnea. For category detalails, please see the Qureshi reference. Scores of 5-7 are considered mild, 8-11 moderate, and 12-15 severe. Asthma Scores are recorded prior to any intervention and at 2 hours after budesonide inhalation suspension/albuterol intervention or saline placebo/albuterol comparator. (NCT00393367)
Timeframe: Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator

InterventionUnits on a scale (Median)
Budesonide Inhalation Suspension (BIS)-3
Placebo (Normal Saline)-3

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Mean Change in Respiratory Rate.

Mean respiratory rate in breaths per minute before treatment minus respiratory rate 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator. (NCT00393367)
Timeframe: Initial rate, minus rate taken 2 hours after budesonide/albuterol intervention or saline/albuterol comparator

InterventionBreaths per minute (Mean)
Budesonide Inhalation Suspension (BIS)-6
Placebo (Normal Saline)-6

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Number of Patients With Treatment Failure

Treatment failure was defined as no therapeutic response (without complete or partial remission) or premature discontinuation during the first 24 weeks from study medication or the study for any reason except complete or partial remission. (NCT00423098)
Timeframe: 12 Weeks and 24 Weeks

,
Interventionparticipants (Number)
At 12 weeks - YesAt 12 weeks - NoAt 24 weeks - YesAt 24 weeks - No
Low Dose25142217
Standard Dose23192121

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Number of Patients With Complete Remission

Complete remission was defined as urine protein/urine creatinine ratio < 0.5 gram urine protein per gram urine creatinine, urine sediment normalized (no cellular casts, < 5 red cells per high power field), and serum creatinine within 10% of normal value. (NCT00423098)
Timeframe: 12 Weeks

,
Interventionparticipants (Number)
YesNo
Low Dose534
Standard Dose933

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Number of Patients With Complete Remission

Complete remission was defined as urine protein/urine creatinine ratio < 0.5 gram urine protein per gram urine creatinine, urine sediment normalized (no cellular casts, < 5 red cells per high power field), and serum creatinine within 10% of normal range according to local lab. (NCT00423098)
Timeframe: 24 Weeks

,
InterventionParticipants (Number)
YesNo
Low Dose831
Standard Dose834

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Number of Patients With Adverse Events and Infections

Safety assessments included collecting all adverse events (AEs), serious adverse events (SAEs), with their severity and relationship to study drug. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening ( NIH criteria Grade 4), causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above. (NCT00423098)
Timeframe: 24 weeks

,
Interventionparticipants (Number)
At least one adverse eventAny severe adverse eventAny drug related adverse eventAny serious adverse eventAny infectionAny severe infectionAny drug related infectionAny serious infection
Low Dose30316417161
Standard Dose357188253104

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Number of Patients With Moderate to Severe Flares

A moderate to severe flare was defined as the occurrence of increased lupus activity after partial or complete remission, based on the presence of 1 BILAG A score or >=3 BILAG B scores. British Isles Lupus Assessment Group (BILAG) index divides lupus activity in 8 organs/systems which are each given a score of A to E. A=disease sufficiently active to need disease modifying treatment; B=problems requiring symptomatic treatment; C=mild stable disease; D=previously affected but currently inactive system; E=the system or organ has never been involved. BILAG score: A=9, B=3, C=1, D/E=0; range(0-72) (NCT00423098)
Timeframe: 12 and 24 weeks

,
Interventionparticipants (Number)
At week 12 - YesAt week 12 - NoAt week 24 - YesAt week 24 - No
Low Dose039039
Standard Dose042141

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Number of Patients With Partial Remission

Partial remission was defined as urine protein/creatinine ratio reduced by at least 50% from baseline and stable serum creatinine within 10% of baseline value) or improved. (NCT00423098)
Timeframe: Baseline to 12 and 24 weeks

,
InterventionParticipants (Number)
At 12 weeks - YesAt 12 weeks - NoAt 24 weeks - YesAt 24 weeks - No
Low Dose11281425
Standard Dose16262022

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Change From Baseline in Overall Disease Activity With British Isles Lupus Assessment Group (BILAG)

BILAG (British Isles Lupus Assessment Group) index divides lupus activity into 8 organs/systems and was based on the principle of the physician's intention to treat, assessing activity in the previous one month. Each organ or system was given a score of A to E, where A = disease that is sufficiently active to require disease modifying treatment; a B = problems requiring symptomatic treatment; C = stable mild disease; D = previously affected but currently inactive system; and E = the system or organ has never been involved. [A=9, B=3, C=1, D/E=0 the score range for each patient will be 0-72]. (NCT00423098)
Timeframe: From Baseline to week 4, week 12 and week 24

,
InterventionUnits on a scale (Mean)
Change from baseline Week 4: (N= 40, 37)Change from baseline Week 12: (N= 41, 35)Change from baseline Week 24: (N= 40, 34)
Low Dose-5.5-8.7-9.4
Standard Dose-4.8-8.6-8.6

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Cumulative Dose of Prednisone Equivalent Corticosteroids (CS)

Corticosteroid use was measured as cumulative dose until 12 and 24 weeks of treatment as well as daily doses at baseline, 12 and 24 weeks. (NCT00423098)
Timeframe: 12 Weeks and 24 Weeks

,
Interventionmg/kg (Mean)
Week 12Week 24
Low Dose68.273.0
Standard Dose106.1114.2

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Duration of Exposure to Study Medication

The duration of exposure was calculated as the date of the last Mycophenolate sodium dose minus the date of the last Mycophenolate sodium dose +1. (NCT00423098)
Timeframe: 24 weeks

Interventiondays (Mean)
Standard Dose164.5
Low Dose157.7

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Change From Baseline in Overall Disease Activity With Systematic Lupus Erythematosus Disease Activity Index (SLEDAI)

SLEDAI stands for Systemic Lupus Erythematosus Disease Activity Index and was a well established global score index based on assessment of 24 items measuring a disease activity in the 10-day period prior to the assessment. SLEDAI item weights range from 1 for fever to 8 for seizures. A maximum theoretical score is 105. Total score range from 1 to 105. A flare has been defined as a SLEDAI score increase of 3 or more to a level of 8 or higher. During flares SLEDAI scores of 25 to 30 are common. (NCT00423098)
Timeframe: From Baseline to week 4, week 12 and week 24

,
InterventionUnits on a scale (Mean)
Change from Baseline to Week 4: (N= 39, 37)Change from Baseline to Week 12: (N= 41, 35)Change from Baseline to Week 24: (N= 39, 34)
Low Dose-7.7-10.3-9.8
Standard Dose-7.4-9.7-10.3

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Survival

Survival (NCT00424489)
Timeframe: Up to 5 years

InterventionParticipants (Count of Participants)
Hematopoietic Stem Cell Transplantation6

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Safety Profiles, Including the Number of Treatment-emergent, Serious, or Unexpected Adverse Events and Other Important Medical Events

(NCT00443430)
Timeframe: Over 12 months maximum study participation per subject

Interventionevents (Number)
Methotrexate Arm1
Methotrexate-Prednisolone-Etanercept Arm2

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Clinical Remission on Medication

6 months of clinical inactive disease (NCT00443430)
Timeframe: 12 months or end of study

Interventionparticipants (Number)
Methotrexate Arm3
Methotrexate-Prednisolone-Etanercept Arm9

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Proportion of Participants Who Attain Inactive Disease by 6 Months

(NCT00443430)
Timeframe: 6 months after initiation of study intervention

Interventionparticipants (Number)
Methotrexate Arm10
Methotrexate-Prednisolone-Etanercept Arm17

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Median Time to Neutrophile Engraftment

Complete blood counts were measured daily after allogeneic transplant. Time to neutrophil engraftment is defined as the number of days it takes to reach an absolute neutrophils count (ANC) >500, counting from the day of transplant. (NCT00481832)
Timeframe: up to 45 days

InterventionDays (Median)
T & B Cell Mobilization Auto & Allo HCT17

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Relapse Rate

Relapse rate (disease recurrence) 3 years after transplant, for participants who received both transplants, as determined by Kaplan-Meier estimation. (NCT00481832)
Timeframe: 3 years

Interventionpercentage of participants (Number)
T & B Cell Mobilization Auto & Allo HCT27

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Overall Survival (OS)

Overall Survival (OS) 3 years after transplant, for participants who received both transplants, as determined by Kaplan-Meier estimation. (NCT00481832)
Timeframe: 3 years

Interventionpercentage of participants (Number)
T & B Cell Mobilization Auto & Allo HCT57

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Overall Mortality Rate

Overall mortality is determined by Kaplan-Meier estimation. The overall morality rate is expressed as the percentage of patients who died for any reason, including disease-related death. (NCT00481832)
Timeframe: 3 years

Interventionpercentage of participants (Number)
T & B Cell Mobilization Auto & Allo HCT56

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Median Time to Platelet Engraftment

Complete blood counts were measured daily after allogeneic transplant. Time to platelet engraftment is defined as the number of days it takes to reach platelet count >20,000, counting from the day of transplant. (NCT00481832)
Timeframe: Up to 45 days

InterventionDays (Median)
T & B Cell Mobilization Auto & Allo HCT11

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Incidence of Chronic Graft Versus Host Disease (GvHD)

The development of GvHD in vaccinated patients of any grade at 6 months. (NCT00481832)
Timeframe: 3 years

InterventionParticipants (Count of Participants)
T & B Cell Mobilization Auto & Allo HCT3

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Incidence of Chemotherapy-associated Pneumonitis

Interstitial pneumonitis (IP) is a risk associated with high-dose carmustine (BCNU) or other chemotherapy drugs used for transplantation. IP is diagnosed by 1) a decrease of >25% in DLCO compared with pre-transplant PFT DLCO values or 2) a drop of 7% or more in oxygen saturation after exertion. (NCT00481832)
Timeframe: 3 years

InterventionParticipants (Count of Participants)
T & B Cell Mobilization Auto & Allo HCT16

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Incidence of Acute Graft Versus Host Disease (GvHD)

The development of GvHD in vaccinated patients of any grade and at 6 months. (NCT00481832)
Timeframe: 6 Months

InterventionParticipants (Count of Participants)
T & B Cell Mobilization Auto & Allo HCT3

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Event-free Survival (EFS)

"Event-free survival (EFS) as determined for participants who receive both planned transplants, for a minimum of 3 years.~Events are defined as disease progression/relapse and death of all causes." (NCT00481832)
Timeframe: 3 years

Interventionpercentage of participants (Number)
T & B Cell Mobilization Auto & Allo HCT35

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Achieving Full Donor Chimerism

Achieving full donor chimerism (donor T cells >95%): Blood was sent for donor cell percentage measured by short tandem repeat (STR) at post-transplant Day 30; Day 60; Day 90; Day 120; Day 180; Day 270; and Day 360. Full donor chimerism is defined as donor CD3+ cells > 95%. (NCT00481832)
Timeframe: Up to 1 year

InterventionParticipants (Count of Participants)
T & B Cell Mobilization Auto & Allo HCT10

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Length of Hospital Stay

(NCT00492973)
Timeframe: days after surgery

Interventiondays (Mean)
Control Group3.5
Corticosteroid2.6

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Knee Society Scores

The Knee Society Score is on a scale of 0 to 100, with 0 being the worst possible score, and 100 being the best possible score. The Knee Society Score takes into account subjective patient reports of pain and functional ability as well as clinical measures of passive knee range of motion. (NCT00492973)
Timeframe: 3 months postoperative

Interventionunits on a scale (Mean)
Control Group87.1
Corticosteroid83.3

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Knee Range of Motion

(NCT00492973)
Timeframe: 3 months

Interventiondegrees (Mean)
Control Group112.5
Corticosteroid112.4

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Complications, Such as Infections, Hospital Readmissions, Manipulations Under Anesthesia, Etc.

(NCT00492973)
Timeframe: any point during the first postoperative year

InterventionNumber of participants with complication (Number)
Control Group0
Corticosteroid3

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Amount of Pain Medication Taken Per Day

(NCT00492973)
Timeframe: Average of 3 days after surgery

Interventionmg/day morphine equivalant (Mean)
Control Group47.8
Corticosteroid46.0

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Number of Participants With An Improvement in Vision, as Measured by an Increase of 15 Letters on the Early Treatment Diabetic Retinopathy Study (EDTRS) Vision Chart.

improvement with combination of niacin and topical prednisolone acetate (NCT00493064)
Timeframe: one year

InterventionParticipants (Count of Participants)
Prospective Active Treatment63

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Change From Baseline to Day 98 Using the WOMAC Pain Question #1

"The WOMAC Index is a validated, 24-question self-administered assessment of three dimensions of pain, stiffness, and physical function for subjects with knee or hip OA. The WOMAC pain question #1 asks subjects to think about the pain you felt in your (study joint) caused by your arthritis during the last 48 hours when walking on a flat surface. This is a visual analog scale (VAS) where the subject indicates pain severity by making a mark through a 100 mm horizontal line with No Pain on the left (0 mm) and Extreme Pain on the right (100 mm). The distance between the left end of the scale and the subject's mark is measured in millimeters. Lower values represent a better outcome." (NCT00521989)
Timeframe: Baseline to Day 98

Interventionmillimeters (Mean)
CRx-102 (2.7/90 mg)-32.4
CRx-102 (2.7/180 mg)-33.2
CRx-102 (2.7/360 mg)-37.3
Prednisolone-40.4
Placebo-34.6

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Absolute C-reactive Protein (CRP) Values at Day 98 - As Treated Population

Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in CRP values in the As-Treated population were calculated. (NCT00551707)
Timeframe: Day 98

Interventionmg/L (Median)
CRx-102 (2.7/180)12.85
CRx-102 (2.7/360)14.25
Prednisolone21.85
Dipyridamole16.60
Placebo2.68

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Percent Change From Baseline to Day 98 in C-reactive Protein (CRP) Values - As Treated Population

Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in CRP values in the As-Treated population were calculated. (NCT00551707)
Timeframe: baseline to day 98

Interventionpercentage of change from baseline (Median)
CRx-102 (2.7/180)-29.90
CRx-102 (2.7/360)-40.84
Prednisolone15.92
Dipyridamole-33.67
Placebo-27.64

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Cumulative Incidence of NK Cell Reconstitution

Cumulative incidence of successful reconstitution to donor level is calculated. (NCT00553202)
Timeframe: At 5 years from HSCT date

InterventionPercentage of participants (Number)
Treatment (Chemotherapy and Allogeneic SCT)48.1

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Overall Survival (OS)

OS - Time from HSCT until death (NCT00553202)
Timeframe: At 5 years from HSCT date

InterventionPercentage of participants (Number)
Treatment (Chemotherapy and Allogeneic SCT)45.9

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Response of Hemangioma (IH) to Treatment

"Response of IH not confined to the dermis will be coded using the following criteria: Progressive disease: >40% increase in volume by MRI, Partial response: >65% reduction in volume by MRI, Complete response: no visual or radiographic evidence of disease, Stable disease: none of the above or <40% increase or <65% decrease in volume by MRI.~Response of superficial IH will be coded using the following criteria (based on RECIST): Progressive disease: >30% increase in IH size, Partial response: >30% reduction in size, Complete response: no evidence of disease, Stable disease: none of the above.~Our first 3 patients showed limits to using MRI volume to measure IH size/response to therapy. Unlike other solid tumors, the superficial distribution of some IH made getting volume by MRI difficult, resulting in smaller tumor estimation compared to clinical assessment. Based on these observations, we amended the protocol to report response based on RECIST criteria instead of change in IH volume." (NCT00555464)
Timeframe: 6 weeks

,
Interventionparticipants (Number)
Progressive DiseasePartial ResponseComplete ResponseStable Disease
Oral Steroid Treatment Group1002
Vincristine Treatment Group0202

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Toxicity to Medications

"Adverse events were closely monitored and recorded at weekly visits during treatment period and for two years after treatment ceased. Laboratory values were taken every other week during the treatment period.~Please see Adverse Events module for more details." (NCT00555464)
Timeframe: Initial visit, 2, 4, 6, 10 and 12 weeks of therapy

,
Interventionparticipants (Number)
Patients with Serious Adverse EventsPatients with Other Adverse Events
Oral Steroid Treatment Group00
Vincristine Treatment Group03

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Percent Probability for Event-free Survival (EFS) for Patients on Arm C at Dose Level 2 (DL2)

EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto. (NCT00557193)
Timeframe: From start of post-induction therapy for up to 10 years

Interventionpercentage probability (Number)
Arm C (Safety/Efficacy Dose Level 2)35.82

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Percent Probability for Event-free Survival (EFS) for Patients on Arm A

EFS time is defined as time from treatment assignment to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto. (NCT00557193)
Timeframe: From start of post-induction therapy for up to 10 years

Interventionpercentage probability (Number)
Arm A (Standard Risk MLL-G)86.67

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Percent Probability for Event-free Survival (EFS) of MLL-R Infants Treated With Combination Chemotherapy With or Without Lestaurtinib at DL2

Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto. EFS will be compared between patients on treatment Arm C at DL2 to those on Arm B. (NCT00557193)
Timeframe: From start of post-induction therapy for up to 10 years.

Interventionpercent probability (Number)
Arm B (IR/HR MLL-R Chemotherapy)38.89
Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)35.82

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Percent Probability of Event Free Survival (EFS) by MRD Status and Treatment Arm

Three-year EFS estimates and 90% CI will be reported by treatment arm and end-induction MRD status. (NCT00557193)
Timeframe: 3 Years from end of Induction)

Interventionpercent probability (Number)
Arm A (MRD Negative)86.05
Arm A (MRD Positive)87.5
Arm B (MRD Negative)47.37
Arm B (MRD Positive)22.73
Arm C (MRD Negative)51.85
Arm C (MRD Positive)27.03

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Describe FLT3 Protein Expression as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts

Described via mean and standard deviation by group. (NCT00557193)
Timeframe: Sampled at the start of induction

InterventionqPCR fold expression ratio (Mean)
Arm A (Standard Risk MLL-G)1.25
Arm B (IR/HR MLL-R Chemotherapy)7.85
Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)5.83

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Pharmacodynamics PIA Levels in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy

Summarized with mean and standard deviation for those with available data in Arm C (NCT00557193)
Timeframe: Sampled between weeks 6-12 from start of induction

InterventionActivity percentage (Mean)
Arm C (Safety/Efficacy Dose Level 2)69.00

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Describe in Vitro Sensitivity as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts

Described via means and standard deviations in samples which have acquired resistance to lestaurtinib (NCT00557193)
Timeframe: At relapse (up to 3 years)

InterventionProportion of cells that are viable (Mean)
Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)0.69

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Describe FLT3 Protein Expression as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts

Described via means and standard deviations in available Arm C relapse samples (NCT00557193)
Timeframe: At relapse (up to 3 years)

InterventionqPCR fold expression ratio (Mean)
Arm C (Safety/Efficacy Dose Level 2)5.73

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Describe in Vitro Sensitivity as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts

Described via means and standard deviations in samples which have primary resistance to lestaurtinib (NCT00557193)
Timeframe: Sampled at the start of induction

InterventionProportion of cells that are viable (Median)
Arm A (Standard Risk MLL-G)0.75
Arm B (IR/HR MLL-R Chemotherapy)0.48
Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)0.47

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Disease-free Survival (DFS)

Disease-free survival is defined as the time interval between the date of attaining a first complete remission (CR) and the date of relapse. Disease free survival (DFS) will compared to conventional therapy vs Non-myeloablative Host Conditioning (NMA HCT). The outcome is reported as the number of participants which never experienced disease relapse (without dispersion). (NCT00568633)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
Allo-HSCT + TLI + ATG5
Best Standard Care9

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Complete Donor Hematopoietic Cell Chimerism

Complete donor hematopoietic cell chimerism was evaluated in transplant recipients. Complete donor chimerism will be assessed as the presence of > 95% donor T-cells (CD3+) in the blood. The outcome is reported as the percentage of participants that achieve complete donor chimerism, a number without dispersion. (NCT00568633)
Timeframe: 2 years

Interventionpercentage of participants (Number)
Allo-HSCT + TLI + ATG56

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Relapse Rate

Relapse will be determined as ≥ 5% blast cells in the bone marrow, not secondary to regeneration after myelosuppressive therapy; OR emergence of extramedullary leukemia; OR the re-emergence of blasts in the peripheral blood. The outcome will be reported as the number and percentage of participants that meet these criteria (a number without dispersion). (NCT00568633)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
Allo-HSCT + TLI + ATG20
Best Standard Care24

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Patients Completing the Intended Therapy in Both Arms

The assessment for completion of the intended therapy (in both arms) will be reported as the percentage of participants, a number without dispersion (NCT00568633)
Timeframe: 2 years

Interventionpercentage of participants (Number)
Allo-HSCT + TLI + ATG100
Best Standard Care81.8

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Overall Survival (OS)

Overall survival defined as the time interval between the date of attaining a first complete remission (CR) and the date of death from any cause. The outcome is reported as the number of participants alive (without dispersion). (NCT00568633)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
Allo-HSCT + TLI + ATG9
Best Standard Care13

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Non-relapse Mortality

Non-relapse mortality is defined as death that occurs after therapy, from any cause except a cause associated with relapse. This will be reported as the number of participants experiencing non-relapse mortality (a number without dispersion). (NCT00568633)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
Allo-HSCT + TLI + ATG1
Best Standard Care2

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Early Graft Loss

Early graft loss means a failure to achieve donor T-cell chimerism of > 5% at any time after transplant. The outcome is reported as the percentage of participants that experience early graft loss, a number without dispersion. (NCT00568633)
Timeframe: 2 years

Interventionpercentage of participants (Number)
Allo-HSCT + TLI + ATG4

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Number of Participants With Progression Free Survival (10 Years) by Treatment

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT00577993)
Timeframe: 10 years

InterventionParticipants (Count of Participants)
Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab59
Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND)58

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Number of Participants With Overall Survival (10 Years) by Treatment

Overall Survival is the time from date of treatment start until date of death due to any cause or last Follow-up within 10 years. (NCT00577993)
Timeframe: 10 Years

InterventionParticipants (Count of Participants)
Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab59
Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND)58

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Graves' Ophthalmopathy Quality of Life Score Using the Short Form-12 (SF-12) Health Survey

Quality of life (QoL) was measured by the SF-12 questionnaire. The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. Physical and Mental Health Composite Scores are computed (combined, scored, and weighted) using the scores of the 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Improvement was defined as a change of ≥ 6 points. (NCT00595335)
Timeframe: baseline, 6 months after first infusion, 12 months after first infusion

,
Interventionunits on a scale (Median)
Baseline QoL physicalBaseline QoL mental6 months QoL physical6 months QoL mental12 months QoL physical12 months QoL mental
Placebo39.946.140.346.146.749.4
Rituximab53.244.345.952.851.856.1

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Failure Rate

The failure rate was defined as a composite variable of CAS decrease of < 2 points or need for additional therapy (excluding cosmetic surgery) for the eye disease. (NCT00595335)
Timeframe: 6 months after first infusion, 12 months after first infusion

,
Interventionpercentage of participants (Number)
Failure rate at 6 monthsFailure rate at 12 months
Placebo7550
Rituximab6946

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Change in Lid Fissure

"The palpebral fissure is the elliptic space between the medial and lateral canthi of the two open eye lids. In adults, this measures about 10mm vertically and 30mm horizontally. The fissure may be increased in vertical height in Graves' disease.~Improvement was defined as a decrease in lid aperture width by ≥3 mm." (NCT00595335)
Timeframe: baseline, 6 months after first infusion

,
Interventionmm (Median)
Lid fissure right eyeLid fissure left eye
Placebo00.5
Rituximab00

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Change in Disease Severity

Disease severity was measured by the NOSPECS Score. This classification scheme of the eye changes in thyroid eye disease was introduced by the American Thyroid Association. It separates patients into seven classes of disease (class 0-6), with 0 being no signs or symptoms and 6 being sight loss. (The acronym is based on the first letter of the defining characteristic of each class, the classification is known as: 'no signs or symptoms; only signs; soft tissue; proptosis; extraocular muscle; cornea; sight loss' (NOSPECS) ). (NCT00595335)
Timeframe: baseline, 6 months after first infusion

,
Interventionparticipants (Number)
Improvement by 1 classImprovement by 2 classesDeteriorationNo change
Placebo8202
Rituximab6223

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Failure Rate at One Year

The failure rate was defined as a composite variable of CAS decrease of < 2 points or need for additional therapy (excluding cosmetic surgery) for the eye disease. (NCT00595335)
Timeframe: one year

Interventionpercentage of participants (Number)
Rituximab46
Placebo50

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Change in Clinical Activity Score (CAS)

The clinical activity score (CAS), for Grave's ophthalmopathy has become a widely accepted tool to assess disease activity and help decide the management of the condition. The CAS, which is based on classical signs of inflammation (pain, redness, and swelling), consists of 7 equally weighted items. The total CAS (as used in this study) may range from 0 to 7. The higher the CAS, the greater degree of inflammation is present. A drop in CAS of 2 or more points suggests an improvement in the inflammatory components of the disease. A CAS ≥3 implies active disease. (NCT00595335)
Timeframe: baseline, 6 months after the first infusion

Interventionunits on a scale (Mean)
Rituximab-1.2
Placebo-1.5

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Change in Proptosis

Eye proptosis is a condition resulting in forward displacement of the globe from its normal position within the orbit. It is measured by computed tomography. Improvement in proptosis was defined as a decrease in proptosis by ≥2 mm. (NCT00595335)
Timeframe: baseline, 12 months after first infusion

,
Interventionmm (Mean)
Proptosis right eyeProptosis left eye
Placebo0.800.0
Rituximab0.820.1

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Change in Extraocular Motility

"Change extraocular motility was assessed using the Gorman diplopia score. Diplopia, commonly known as double vision, is the simultaneous perception of two images of a single object that may be displaced horizontally, vertically, or diagonally (i.e., both vertically and horizontally) in relation to each other. It is usually the result of impaired function of the extraocular muscles, where both eyes are still functional but they cannot converge to target the desired object.~The Gorman diplopia score includes four categories: 1) no diplopia (absent), 2) diplopia when the patient is tired or awakening (intermittent), 3) diplopia at extremes of gaze (inconstant), and 4) continuous diplopia in the primary or reading position (constant)." (NCT00595335)
Timeframe: baseline, 6 months after first infusion, 12 months after first infusion

,
Interventionunits on a scale (Median)
Change baseline-6 monthsChange baseline-12 months
Placebo2.51.5
Rituximab32

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Day 56 Treatment Success

Definition of Treatment Failure: No Response according to the following: A) Skin: 1) No change in GVHD stage by day 14; 2) Gut: No change in GVHD stage by Day 7; 3) Liver: No change in GVHD stage by Day 21. B) Progressive Disease (PD): 1) Skin/Gut: Increase in Stage by 72 hours from the start of therapy; 2) Liver: Increase in Stage by Day 14; 3) Initiation of 2nd line treatment at any time for acute GVHD: 4) Any new organ involvement by acute GVHD. C) Inability to Taper: 1) Patient still on >1 mg/kg/d of methylprednisolone equivalent at 1 month. 2) Patient still on > 0.5 mg/kg/d of methylprednisolone equivalent at 2 months; 3) Death from GVHD. Definition of Treatment Success: Participants not defined above in Treatment Failure definition. Baseline biopsy with Acute GVHD assessed weekly until last ECP procedure (anticipated Day 63). At 6 months follow up with a phone call for survival and GVHD status. (NCT00609609)
Timeframe: Day 1 to Day 63 (approximately 9 weeks), Acute GVHD scored weekly.

,
Interventionpercentage of participants (Number)
Skin-onlyVisceral InvolvementTotal
Corticosteroids574353
ECP + Corticosteroids724765

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Non-relapse Mortality (NRM) at 6 Months

Percentage of participants at 6 months whose deaths were without relapse/recurrence. (NCT00609609)
Timeframe: 6 months

Interventionpercentage of participants (Number)
Corticosteroids19.6
ECP + Corticosteroids20.0

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Percentage of Participants Alive, In Remission & Without GVHD Progression Day 28 & Day 56

Percentage meeting steroid milestone who were alive, in remission and did not have GVHD progression before Day 28 or Day 56. (NCT00609609)
Timeframe: Up to day 56

,
Interventionpercentage of participants (Number)
Day 28 Steroid dose Day 56 steroid dose < 0.1mg/kg
Corticosteroids1030
ECP + Corticosteroids23.543

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The Number of Lipoma Increased in Volume.

(NCT00624416)
Timeframe: After four weeks of treatment up to one year.

InterventionLipomas (Number)
Prednisolone and Isoproteronol9

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The Number of Subjects Elected to Have the Lipoma Removed.

(NCT00624416)
Timeframe: After four weeks up to one year.

Interventionparticipants (Number)
Prednisolone and Isoproteronol8

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The Average Percent Volume Reduction in the Lipoma.

(NCT00624416)
Timeframe: Baseline and 4 weeks

InterventionPercent Volume reduction (cc^3) (Mean)
Prednisolone and Isoproteronol50

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Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response

ACR20 response: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP. (NCT00634933)
Timeframe: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,
Interventionpercentage of participants (Number)
Week 2Week 4Week 8Week 12Week 16Week 20Week 24
Placebo17.631.131.131.141.947.343.2
TRU-015 Induction Dose26.034.242.549.361.664.467.1
TRU-015 Single Dose21.334.744.052.064.062.761.3

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Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response

ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP. (NCT00634933)
Timeframe: Week 2, 4, 8, 12, 16, 20, 28, 32, 36, 40, 44, 48, 52

,,
Interventionpercentage of participants (Number)
Week 2Week 4Week 8Week 12Week 16Week 20
Placebo0.06.812.214.916.216.2
TRU-015 Induction Dose6.86.88.213.731.528.8
TRU-015 Single Dose8.08.010.716.030.728.0

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Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response

ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP. (NCT00634933)
Timeframe: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,
Interventionpercentage of participants (Number)
Week 2Week 4Week 8Week 12Week 16Week 20Week 24
Placebo0.01.41.41.46.82.72.7
TRU-015 Induction Dose1.40.01.42.76.86.89.6
TRU-015 Single Dose1.31.32.72.78.06.79.3

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Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28

The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. (NCT00634933)
Timeframe: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,
Interventionpercentage of participants (Number)
Week 2: good responseWeek 2: moderate responseWeek 2: no responseWeek 4: good responseWeek 4: moderate responseWeek 4: no responseWeek 8: good responseWeek 8: moderate responseWeek 8: no responseWeek 12: good responseWeek 12: moderate responseWeek 12: no responseWeek 16: good responseWeek 16: moderate responseWeek 16: no responseWeek 20: good responseWeek 20: moderate responseWeek 20: no responseWeek 24: good responseWeek 24: moderate responseWeek 24: no response
Placebo1.433.864.95.439.255.48.144.647.39.539.251.418.940.540.517.637.844.614.944.640.5
TRU-015 Induction Dose2.739.757.58.245.246.612.353.434.216.452.131.520.556.223.326.054.819.230.150.719.2
TRU-015 Single Dose6.738.754.714.741.344.014.744.041.321.353.325.334.741.324.029.352.018.726.746.726.7

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Physician Global Assessment (PGA) of Disease Activity

Physician Global Assessment of Disease Activity was measured on a 0 to 10 point scale, where 0 = no disease activity and 10 = extreme disease activity. (NCT00634933)
Timeframe: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,
Interventionunits on a scale (Mean)
BaselineWeek 2Week 4Week 8Week 12Week 16Week 20Week 24
Placebo6.85.55.05.04.84.64.44.3
TRU-015 Induction Dose6.65.24.94.44.33.63.63.6
TRU-015 Single Dose6.45.15.04.14.13.73.83.7

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Visual Analogue Scale for Pain (VAS-pain)

100 millimeter (mm) line (Visual Analog Scale) marked by participant. Intensity of pain range (over past week): 0 = no pain to 100 = worst possible pain. (NCT00634933)
Timeframe: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,
Interventionmm (Mean)
BaselineWeek 2Week 4Week 8Week 12Week 16Week 20Week 24
Placebo65.453.053.656.454.351.151.149.2
TRU-015 Induction Dose61.649.649.047.044.840.839.143.9
TRU-015 Single Dose62.547.748.945.842.339.339.539.2

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Percentage of Participants With an American College of Rheumatology 50% (ACR 50) Response at Week 24

ACR50 response: greater than or equal to (>=) 50 percent (%) improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ-DI]); and C-Reactive Protein (CRP). (NCT00634933)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Placebo16.2
TRU-015 Single Dose29.3
TRU-015 Induction Dose27.4

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Number of Tender Joints

The number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. (NCT00634933)
Timeframe: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,
Interventiontender joints (Mean)
BaselineWeek 2Week 4Week 8Week 12Week 16Week 20Week 24
Placebo17.013.611.911.711.09.49.09.4
TRU-015 Induction Dose17.713.011.610.19.68.47.67.6
TRU-015 Single Dose16.811.910.79.88.87.37.68.1

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Number of Swollen Joints

The number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. (NCT00634933)
Timeframe: Baseline. Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,
Interventionswollen joints (Mean)
BaselineWeek 2Week 4Week 8Week 12Week 16Week 20Week 24
Placebo12.29.57.87.07.66.16.06.2
TRU-015 Induction Dose13.910.29.07.77.15.95.15.0
TRU-015 Single Dose12.39.08.56.96.05.14.84.7

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Patient Global Assessment (PtGA) of Disease Activity

Measured using a 0-10 point scale, where 0 = no disease activity and 10 = extreme disease activity. (NCT00634933)
Timeframe: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,
Interventionunits on a scale (Mean)
BaselineWeek 2Week 4Week 8Week 12Week 16Week 20Week 24
Placebo7.36.26.06.25.96.65.55.3
TRU-015 Induction Dose7.05.65.65.35.24.64.54.7
TRU-015 Single Dose6.95.65.45.24.84.44.54.6

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Health Assessment Questionnaire Disability Index (HAQ-DI)

HAQ-DI: participant-reported assessment of ability to perform tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) hygiene; and 8) common activities over past week. Each item scored on 4-point Likert scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The overall disability index computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. (NCT00634933)
Timeframe: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,
Interventionunits on a scale (Mean)
BaselineWeek 2Week 4Week 8Week 12Week 16Week 20Week 24
Placebo1.81.51.41.51.51.41.41.4
TRU-015 Induction Dose1.61.31.31.21.11.11.01.0
TRU-015 Single Dose1.71.41.41.31.31.21.21.2

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Disease Activity Score Based on 28-joints Count (DAS28)

DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and participant's general health visual analog scale (scores ranging 0 [very well] to 100 mm [extremely bad]). DAS28 less than or equal to (=<) 3.2 = low disease activity, DAS28 greater than (>) 3.2 to 5.1 = moderate to high disease activity. (NCT00634933)
Timeframe: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,
Interventionunits on a scale (Mean)
BaselineWeek 2Week 4Week 8Week 12Week 16Week 20Week 24
Placebo6.15.45.25.15.04.74.74.7
TRU-015 Induction Dose6.15.35.04.74.64.34.14.0
TRU-015 Single Dose5.85.14.94.64.33.94.04.1

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Number of Participants With a Response

Response - Complete remission (CR): Normalization peripheral blood & bone marrow 5% or & platelet count >100x10^9/L; CR with incomplete platelet recovery (CRp): CR but platelet count <100x10^9/L. CR with incomplete recovery (CRi): CR but platelet count <100x10^9/L or absolute neutrophil count < 1x10^9/L. Partial response (PR): As above except for presence of 6-25% marrow blasts. Lymphoblastic lymphoma (& ALL subtypes with extramedullary disease): CR - disappearance all known disease. PR - >50% decrease in tumor size using sum of product, includes 50% volume decrease in lesions measurable in 3 dimensions. No Response (NR) - No significant change (includes stable disease). Lesions decreased size but <50% or lesions with slight enlargement <25% increase in size. Progressive Disease (PD): Appearance new lesions, 25% or > increase in size existing lesions (>50% if 1 lesion & <2). (NCT00671658)
Timeframe: Response assessed following first 21 day course up to end of treatment with 8 cycles, up to 210 days

InterventionParticipants (Number)
Complete Response (CR)Complete Response without Platelet RecoveryPartial Response (PR)
HYPER-CVAD19834

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Change in Serum Osteocalcin

Change in serum markers of bone formation (osteocalcin) from Day 0 to Day 28. (NCT00682357)
Timeframe: Change from Baseline Visit to Day 28

Interventionng/mL (Mean)
Group 1 - Standard Dose-2.18
Group 2 - Low Dose-0.45
Group 3 - Placebo-1.10

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Change in Serum Cortisol

Cortisol levels were measured over 28 days. Outcome represents mean change in cortisol level between baseline visit and day 28. (NCT00682357)
Timeframe: Change from Baseline Visit to Day 28

Interventionmcg/dL (Mean)
Group 1 - Standard Dose-1.16
Group 2 - Low Dose0.65
Group 3 - Placebo1.30

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Change in Testosterone

Outcome represents the mean change in testosterone level from baseline visit to day 28. (NCT00682357)
Timeframe: Change from Baseline Visit to Day 28

Interventionng/dL (Mean)
Group 1 - Standard Dose0.08

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Change in Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b)

Outcome represents the mean change in serum biomarkers of bone breakdown (TRACP-5b) from baseline visit to day 28. (NCT00682357)
Timeframe: Change from Baseline Visit to Day 28

InterventionU/L (Mean)
Group 1 - Standard Dose-0.153
Group 2 - Low Dose-0.295
Group 3 - Placebo-0.148

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Ocular Itching at Baseline (Day 0)

A baseline CAC was performed on Day 0. Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 6, Day 7, Day 27 and Day 28. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. (NCT00689078)
Timeframe: 3, 5, 7 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
3 minutes post-CAC5 minutes post-CAC7 minutes post-CAC
Alrex2.613.063.08
Pred Forte2.532.923.03
Pred Mild3.083.473.44
Tears Naturale2.52.752.83

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Ocular Itching at Day 7

Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 7. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. (NCT00689078)
Timeframe: 3, 5, 7 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
3 minutes post-CAC5 minutes post-CAC7 minutes post-CAC
Alrex2.092.031.88
Pred Forte2.112.111.97
Pred Mild2.282.692.75
Tears Naturale2.031.941.72

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Ocular Redness at Day 6

Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 6. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed. (NCT00689078)
Timeframe: 7, 15, 20 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
7 minutes post-CAC15 minutes post-CAC20 minutes post-CAC
Alrex1.842.132.03
Pred Forte21.972
Pred Mild2.222.412.31
Tears Naturale2.112.282.17

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Ocular Redness at Day 28

Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 28. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed. (NCT00689078)
Timeframe: 7, 15, 20 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
7 minutes post-CAC15 minutes post-CAC20 minutes post-CAC
Alrex1.691.691.69
Pred Forte1.581.811.5
Pred Mild1.962.111.86
Tears Naturale1.811.941.72

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Ocular Redness at Day 27

Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 27. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed. (NCT00689078)
Timeframe: 7, 15, 20 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
7 minutes post-CAC15 minutes post-CAC20 minutes post-CAC
Alrex1.441.631.53
Pred Forte1.721.721.53
Pred Mild2.142.111.89
Tears Naturale1.561.721.72

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Ocular Itching at Day 27

Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 27. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. (NCT00689078)
Timeframe: 3, 5, 7 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
3 minutes post-CAC5 minutes post-CAC7 minutes post-CAC
Alrex1.752.092
Pred Forte2.142.172.03
Pred Mild2.432.642.64
Tears Naturale2.031.841.72

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Ocular Redness at Baseline (Day 0)

A baseline CAC was performed on Day 0. Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 6, Day 7, Day 27 and Day 28. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed. (NCT00689078)
Timeframe: 7, 15, 20 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
7 minutes post-CAC15 minutes post-CAC20 minutes post-CAC
Alrex1.862.112
Pred Forte2.112.332.22
Pred Mild2.112.312.28
Tears Naturale2.082.252.06

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Ocular Itching at Day 6

Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 6. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. (NCT00689078)
Timeframe: 3, 5, 7 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
3 minutes post-CAC5 minutes post-CAC7 minutes post-CAC
Alrex2.062.412.31
Pred Forte2.172.442.17
Pred Mild2.192.592.72
Tears Naturale2.332.532.14

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Ocular Itching at Day 28

Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 28. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. (NCT00689078)
Timeframe: 3, 5, 7 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
3 minutes post-CAC5 minutes post-CAC7 minutes post-CAC
Alrex2.0321.78
Pred Forte1.831.971.89
Pred Mild2.252.642.71
Tears Naturale1.751.781.56

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Ocular Redness at Day 7

Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 7. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed. (NCT00689078)
Timeframe: 7, 15, 20 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
7 minutes post-CAC15 minutes post-CAC20 minutes post-CAC
Alrex1.591.591.47
Pred Forte2.081.831.72
Pred Mild1.531.691.78
Tears Naturale1.591.661.5

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Mean Aqueous Humor Prednisolone Acetate Concentration

(NCT00699803)
Timeframe: 4 hours

Interventionng/mL (Mean)
T-Pred102.5
Pred Forte127.5

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Overall EFS Rate for the Combined Cohort of Standard- and High-Risk Patients (Who Receive the Final Chosen Dose of Dasatinib)

An event is defined as: Induction failure, relapse at any site, secondary malignancy, or death. (NCT00720109)
Timeframe: From the time entry on study to first event or date of last follow-up, assessed up to 7 years

Interventionpercentage of patients (Number)
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)79.8
Standard-risk83.2
High-risk66.7

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Contribution of Dasatinib on Minimal Residual Disease (MRD) After Induction Therapy

Percent of patients MRD Positive (MRD > 0.01%) at End of Induction. (NCT00720109)
Timeframe: At the end of induction therapy (at 5 weeks)

InterventionPercentage of participants (Number)
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)40.7
Standard-risk29.2
High-risk100.0

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Event-Free Survival (EFS) of Patients With Standard-risk Disease Treated With Dasatinib in Combination With Intensified Chemotherapy

Event-Free Survival (EFS) curves will be constructed using the Kaplan-Meier life table method with standard errors computed using the method of Peto and Peto. A 1-sided 95% confidence interval for EFS will be constructed. (NCT00720109)
Timeframe: At 3 years

InterventionPercent probability (Number)
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)79.8
Standard-risk83.2
High-risk66.7

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Feasibility and Toxicity of an Intensified Chemotherapeutic Regimen Incorporating Dasatinib for Treatment of Children and Adolescents With Ph+ ALL Assessed by Examining Adverse Events

Number of patients in safety cohort with dose limiting toxicity (DLT)(including treatment delay) (NCT00720109)
Timeframe: Weeks 3 through 23 of treatment (From week 3 Induction through Intensification Block 1)

InterventionPts with DLTs (Number)
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)1

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Percent of Patients MRD Positive (MRD > 0.01%) at End of Consolidation

A 1-sample Z-test of proportions (alpha=5%, 1-sided test) will be used. (NCT00720109)
Timeframe: At end of consolidation (at 11 weeks)

InterventionPercentage of participants (Number)
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)10.5
Standard-risk0
High-risk66.7

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Complete Response Rate

To evaluate the complete (CR) response rate with relapsed follicular NHL treated with ESHAP chemotherapy for cytoreduction (2 cycles) followed by Ibritumomab tiuxetan (Zevalin) radioimmunotherapy (NCT00732498)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
ESHAP Followed by Zevalin and Rituximab10

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Median Time to Progression

To evaluate the median TTP of patients with relapsed follicular NHL treated with ESHAP chemotherapy for cytoreduction (2 cycles) followed by Ibritumomab tiuxetan (Zevalin) radioimmunotherapy. (NCT00732498)
Timeframe: 5 years

Interventionmonths (Median)
ESHAP Followed by Zevalin and Rituximab10

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Progression-free Survival at 1 Year

To evaluate the 1-year progression-free survival (PFS) of patients with relapsed follicular non-Hodgkin's lymphoma (NHL) treated with ESHAP chemotherapy for cytoreduction (2 cycles) followed by Ibritumomab tiuxetan (Zevalin) radioimmunotherapy. (NCT00732498)
Timeframe: 1 year

Interventionpercentage of participants (Number)
ESHAP Followed by Zevalin and Rituximab38

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Overall Response Rate

To evaluate the overall (ORR) response rate with relapsed follicular NHL treated with ESHAP chemotherapy for cytoreduction (2 cycles) followed by Ibritumomab tiuxetan (Zevalin) radioimmunotherapy. Descriptive and summary statistics for demographic and clinical variables obtained. The incidences of reported adverse events (AEs) tabulated. Kaplan-Meier survival analysis for PFS and OS performed on TPP. All the analyses were performed using Stata [12]. (NCT00732498)
Timeframe: 5 years

Interventionpercentage of participants (Number)
ESHAP Followed by Zevalin and Rituximab77.3

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Global Perceived Effect

Satisfaction. Number of participants with positive perceived global satisfaction. (NCT00733096)
Timeframe: 1 month

Interventionparticipants (Number)
Steroid23
Etanercept15
Saline17

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Medication Reduction

Number of people who reduced medications (NCT00733096)
Timeframe: 1 month

Interventionparticipants (Number)
Steroid17
Etanercept9
Saline14

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Oswestry Disability Score

0-100%. 0= no disability, 100% is complete disability (NCT00733096)
Timeframe: 1 month

Interventionpercentage of disability out of 100% (Mean)
Steroid22.4
Etanercept40.26
Saline30.00

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Numerical Rating Leg Pain Score

0-10 pain score. 0= no pain, 10= worst imaginable pain. (NCT00733096)
Timeframe: 1 month

Interventionunits on a scale (Mean)
Steroid2.54
Etanercept3.56
Saline3.78

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Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery

Macular edema (thickening of the center of the back of the eye) was defined as 30% or greater increase from pre-operative baseline measurement in central subfield macular thickness as measured using Optical Coherence Tomography(OCT). (NCT00782717)
Timeframe: 3 Months

InterventionPercentage of patients (Number)
NEVANAC3
Nepafenac Vehicle17

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Percent of Patients With a Decrease of More Than 5 Letters in Best-corrected Visual Acuity (BCVA).

BCVA was measured using the procedure developed for the Early Treatment Diabetic Retinopathy Study. (NCT00782717)
Timeframe: From Day 7 to Day 90 (or Early Exit)

InterventionPercentage of patients (Number)
NEVANAC6
Nepafenac Vehicle12

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Survival

survival rate will be evaluated at 6 months,1 year, 2 year, 3 year, 4 year, 5 year after the transplant (NCT00787722)
Timeframe: 6 months, 1 year, 2 year, 3 year, 4 year, 5 year - after the transplant

InterventionParticipants (Count of Participants)
6 months survival1 year survival2 year survival3 year survival4 year survival5 year survival
Hematopoietic Stem Cell Transplantation131212111111

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Quality of Life (QOL) Short Form - 36 (SF-36)

SF- 36 is a self-administered quality of life exam. The evaluation of the results was done by attributing scores to each question, which were then transformed into a scale ranging from 0 to 100, where 0 corresponds to the worst quality of life and 100 to the best. (NCT00787722)
Timeframe: pre-transplant 12mo and 5 years

Interventionscore on a scale (Median)
Pretransplant1 Year Post Transplant5 Year Post Transplant
Hematopoietic Stem Cell Transplantation30.8352.6961.63

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Disability Score: Expanded Disability Status Scale (EDSS)

"Disability scores (disease improvement defined by at least a 1 point increase in the Expanded Disability Status Scale (EDSS) on consecutive evaluations at least three months apart.~The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability." (NCT00787722)
Timeframe: pretransplant 6 month, 5 year

Interventionscore on a scale (Mean)
Pretransplant Disability Score (EDSS)1 Year Post Transplant Disability Score (EDSS)5 Year Post Transplant Disability Score (EDSS)
Hematopoietic Stem Cell Transplantation4.42.83.3

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NMO-IgG Aquaporin- 4 Autoantibody Titer

NMO-IgG aquaporin- 4 autoantibody titer will be tested pretransplant and post transplant. (NCT00787722)
Timeframe: Pretransplant and 5 year Post Transplant

InterventionParticipants (Count of Participants)
Pretransplant NMO ASSAY positive5 year post transplant NMO Assay positive
Hematopoietic Stem Cell Transplantation112

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Number of Patients Who Require No Device Assistance for Ambulation

No Device Assistance Needed for Ambulation evaluated at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year - after the transplant (NCT00787722)
Timeframe: 6 months, 1 year, 2 year, 3 year, 4 year, 5 year - after the transplant

InterventionParticipants (Count of Participants)
Pre HSCT- No Assistive Required6 Mos Post HSCT- No Assistive Device Required1 Year Post HSCT- No Assistive Device Required2 Year Post HSCT- No Assistive Device Required3 Year Post HSCT- No Assistive Device Required4 Year Post HSCT- No Assistive Device Required5 Year Post HSCT- No Assistive Device Required
Hematopoietic Stem Cell Transplantation69109889

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Post HSCT Immune -Modulating Medication and Relapse

Number of immune - modulating medication and relapse evaluated 5 year - after the transplant (NCT00787722)
Timeframe: Pre transplant and 6 months, 1 year, 2 year, 3 year, 4 year and 5 year after transplant

InterventionParticipants (Count of Participants)
Pre HSCT - Immunosuppression/Relapse Rate6 Mos Post HSCT Immunosuppression/ Relapse Rate1 Year Post HSCT Immunosuppression/Relapse Rate2 Year Post HSCT Immunosuppression/Relapse Rate3 Year Post HSCT Immunosuppression/Relapse Rate4 Year Post HSCT Immunosuppression/Relapse Rate5 Year Post HSCT Immunosuppression Relapse Rate
Hematopoietic Stem Cell Transplantation (HSCT)12113011

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Relapse-free Survival (RFS) After Allogeneic Stem Cell Transplantation

Will be estimated using the method of Kaplan-Meier. (NCT00792948)
Timeframe: 12 months

InterventionProbability of 12-month RFS (Number)
Treatment0.83

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Overall Survival (OS)

OS will be estimated using the method of Kaplan-Meier. (NCT00792948)
Timeframe: From the date of initial registration on the study until death from any cause, assessed up to 5 years

InterventionProbability of surviving 12 months (Number)
Treatment0.88

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Continuous Complete Remission (CCR) Rate

Will be testing using an exact binomial test (NCT00792948)
Timeframe: 18 months

Interventionpercentage of participants (Number)
Treatment57

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Change in Hearing

Hearing was measured as ipsilesional pure-tone threshold at Baseline, 1month, 2months, 6months, 12month, 18months and 24 months follow-up. Hearing level was taken as the average threshold across 0.5, 1, 2 and 3KHz. (NCT00802529)
Timeframe: Baseline, 1,2,6,12,18 and 24months after initial treatment

,
InterventiondB (Mean)
Baseline1month2months6months12months18months24months
Gentamicin51.552.1848.9945.4847.3444.8249.1
Steroid (Methylprednisolone)53.2549.2949.8346.6747.0248.4446.9

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Vertigo Attacks

The number of vertigo attacks between 18-24months follow-up were taken retrospectively during a face-to-face appointment at 24 months follow-up and compared to 6 month pre-enrollment baseline (as per Committee on Hearing and Equilibrium guidelines). (NCT00802529)
Timeframe: 6month pre-enrollment baseline, 18-24 months after initial treatment

,
InterventionVertigo Attacks (Mean)
Baseline18-24months
Gentamicin19.932.5
Steroid (Methylprednisolone)16.41.6

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Change in Speech Discrimination

"Speech discrimination was measured at Baseline, 1month, 2months, 6months, 12month and 24 months follow-up.~Speech discrimination was assessed by means of ipsilesional suprathreshold word recognition (%). Arthur Boothroyd's isophonemic word lists (AB wordlists, Guymark, Southampton) comprising sets of 10 words were played to the ipsilesional ear at the low-frequency pure-tone threshold of 0·5, 1 and 2 kHz +30dB with masking sound in the contralesional ear if necessary. The formula for masking level was: low-frequency pure-tone threshold in ipsilesional ear - bone conduction mean threshold (0·5, 1 and 2KHz) in contralesional ear - 40dB. Speech loudness and masking were rounded to the nearest 5dB. Step increments and decrements of 10dB for speech loudness and masking were used to attain the maximum speech discrimination score." (NCT00802529)
Timeframe: Baseline, 1,2,6,12 and 24months after initial treatment

,
InterventionPercentage correct (Mean)
Baseline1month2months6months12months24months
Gentamicin72.1069.4374.3176.3571.5864.99
Steroid (Methylprednisolone)64.9771.7876.1075.6373.4376.32

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Overall Response

Complete response (CR) was defined as normalization of peripheral blood and bone marrow with <5% blasts, a peripheral absolute neutrophil count (ANC) >/= 1 * 10^9/l, hemoglobin >/= 100g/l, and a platelet count >/= * 10^9/l, Partial Response (PR) was defined as transfusion independence with a peripheral blood ANC >=/ 0.05 * 10^9/l, a platelet count >/= 20 * 10^9/l, and a hemoglobin >/= 40 g/l. Hematologic improvement was defined as a clinically relevant increase in hemoglobin, platelets or absolute neutrophil count. (NCT00806598)
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Assessed first at 3 months on study, continuing monthly up to 3 years.

Interventionparticipants (Number)
Complete ResponsePartial ResponseHematological Improvement
Thymoglobulin + Cyclosporin884

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Number of Participants With Clinically Significant Atrial Arrhythmias at 6 Weeks

Clinically significant atrial arrhythmias include ER, urgent care, or hospitalization for atrial fibrillation, cardioversion for atrial fibrillation, or atrial fibrillation requiring an increase in anti-arrhythmia medication (NCT00807586)
Timeframe: 6 weeks

InterventionParticipants (Count of Participants)
Steroid4
Placebo12

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Cardiac Pain Assessment

Perception of cardiac pain assessed by a numerical pain scale (0= no pain; 10=worst pain imaginable) (NCT00807586)
Timeframe: one day and one week

,
Interventionunits on a scale (Mean)
Pain Scale Day 1Pain Scale Week 1
Placebo1.50.6
Steroid0.90.8

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Repeat Intervention

Need for repeat ablation (NCT00807586)
Timeframe: 3 months

InterventionParticipants (Count of Participants)
Steroid2
Placebo8

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Means Aqueous Humor Prednisolone Acetate Concentration

(NCT00854061)
Timeframe: 35 days

Interventionng/mL (Mean)
T-Pred100.02
Pred Forte131.65

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Number of Living Donor Transplant Candidates That Are Transplanted

Number of living donor transplant candidates who convert to a negative flow T- and B-cell crossmatch via desensitization and are subsequently transplanted (NCT00908583)
Timeframe: 1 year post baseline

Interventionparticipants (Number)
All Study Participants19

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Acute Rejection Rate

Acute rejection rate at 6 months of all desensitized and transplanted patients (NCT00908583)
Timeframe: 6 months post transplant

Interventionparticipants (Number)
All Transplanted Participants3

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Overall Safety of Bortezomib

Incidence of grade 3 and above non-hematologic toxicities. Incidence of grade 4 hematologic toxicities. Incidence of all grades of peripheral neuropathy. Incidence of Cytomegalovirus (CMV), Polyomavirus Allograft Nephropathy (PVN), and Posttransplant Lymphoproliferative Disorder (PTLD). (NCT00908583)
Timeframe: Study Day 62

,,,,,,,
Interventionparticipants (Number)
Incidence of CTCAE Grade 3 Anemia (<8.0-6.5 g/dL)Incidence of CTCAE Grade 4 Anemia (<6.5g/dL)Incidence of CTCAE Grade 3 ThrombocytopeniaIncidence of CTCAE Grade 4 ThrombocytopeniaIncidence of CTCAE Grade 3 NeutropeniaIncidence of CTCAE Grade 4 NeutropeniaIncidence of new onset level 1 PNIncidence of new onset level 2 PNIncidence of new onset level 3 PNIncidence of new onset level 4 PNIncidence of new onset level 5 PNCMV D+/R- StatusCMV Viremia or Invasive DiseasePolyomavirus Allograft Nephropathy (PVN)Malignancy
Phase 1 Cycle 2202010033100000
Phase 1, Cycle 1101000151010000
Phase 2 Cycle 2000000230000000
Phase 2, Cycle 1100000320100000
Phase 3, Cycle 1001000021000000
Phase 3, Cycle 2001000110010000
Phase 4, Single Stage000000000000000
Phase 5, Single Stage100000100000000

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Number of Patients Whose Cytotoxic Panel Reactive Antibody (PRA) is Decreased by 50%

Number of patients on the waiting list whose cytotoxic PRA is decreased by 50%. (NCT00908583)
Timeframe: 46 days

Interventionparticipants (Number)
All Study Participants6

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Number of Subjects With at Least 50% Reduction in the Frequency of Days With Moderate or Severe Migraine in the 4 Week Post Injection Compared to the 4 Week Pre-injection Baseline Period

The baseline frequency will be the number of calendar days with moderate or severe migraine during the 4 week period prior to injection, and the follow-up frequency will be the number of calendar days with migraine during the 4 week period following injection. (NCT00915473)
Timeframe: 4 weeks pre-injection baseline, 4 weeks post-injection

Interventionparticipants (Number)
Active Injection10
Placebo Injection9

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Mean Frequency of Days With a Migraine

(NCT00915473)
Timeframe: 4 weeks post-injection

,
Interventiondays per 4 weeks (Mean)
SevereAt Least ModerateAt Least Mild
Active Injection3.47.09.3
Placebo Injection2.97.810.4

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Mean Number of Days With Acute Medication Use

"Acute medication use meant the consumption of a drug to abort or terminate a headache." (NCT00915473)
Timeframe: 4 weeks post-injection

Interventiondays per 4 weeks (Mean)
Active Injection6.7
Placebo Injection7.7

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Mean Number of Hours With Moderate or Severe Migraine

(NCT00915473)
Timeframe: 4 weeks post-injection

Interventionhours per 4 weeks (Mean)
Active Injection60
Placebo Injection58

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Prednisone-associated Toxicity as Assessed by Myopathy

Assessed by mean change from baseline to day 42 using Manual Muscle Testing measure. The degree of resistance against pressure applied by tester was measured on a 5-point scale. A score of 5 indicates the patient can hold the position against maximum to strong resistance. A score of 0 indicates the patient has no resistance against pressure. Testing included upper and lower extremities: shoulder (deltoid at 90 degrees), and hip and knee in a sitting position. (NCT00929695)
Timeframe: Baseline and then weekly until 42 days after starting treatment

Interventionunits on a scale (Mean)
Group A (Low-dose)-0.18
Group B (Standard-dose)-0.18

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Prednisone-associated Toxicity as Assessed by Quality of Life

Patients completed the MD Anderson Symptom Inventory (MDASI), which is a quality of life questionnaire validated for oncology/transplant patients. On a 1-10 point scale, patients scored the degree of severity of symptoms or the degree of interference in feelings or function due to symptoms at baseline or in the previous week. A score of 1 indicates symptom is not present or does not interfere with feelings or function. A score of 10 indicates the symptom is as bad as you can imagine or interferes completely with feelings or function. The mean change in score from baseline to day 42 was measured. (NCT00929695)
Timeframe: Baseline and then every other week until 42 days after starting treatment

Interventionunits on a scale (Mean)
Group A (Low-dose)-2.3
Group B (Standard-dose)-1.9

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Progression to Grade III-IV Acute GVHD

Diagnosed and graded according to standard established criteria. Measure is percent of patients with baseline scores of IIa (Group A) or IIb (Group B) who progressed to more severe GVHD (Grade III/IV). Percentage estimated by cumulative incidence methods. (NCT00929695)
Timeframe: At approximately 100 days after transplant

Interventionpercentage of participants (Number)
Group A (Low-dose)6
Group B (Standard-dose)13

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Secondary Therapy for Acute GVHD Beyond Prednisone

This includes any intervention intended to control acute GVHD through an immunosuppressive effect from oral or parenteral administration of any systemic medication not given previously. This does not include topical therapy, an increase in the dose of glucocorticoids or the resumption of treatment after previous discontinuation or any increase in the dose of immunosuppressive medication previously administered for GVHD prophylaxis, or reinstatement of GVHD prophylaxis previously discontinued. A change in treatment from cyclosporine to tacrolimus or vice versa because of drug toxicity is not considered secondary therapy, but any change made because of uncontrolled GVHD is considered secondary therapy. Percentage is estimated by cumulative incidence methods. (NCT00929695)
Timeframe: At approximately 100 days after transplant

Interventionpercentage of participants (Number)
Group A (Low-dose)23
Group B (Standard-dose)7

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Recurrent or Progressive Malignancy

Percentage of relapse estimated by cumulative incidence methods (NCT00929695)
Timeframe: At 12 months after the start of prednisone therapy

Interventionpercentage of participants (Number)
Group A (Low-dose)21
Group B (Standard-dose)21

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Chronic Extensive GVHD

Percentage of patients with chronic extensive GVHD, estimated by cumulative incidence methods (NCT00929695)
Timeframe: At 12 months after the start of prednisone therapy

Interventionpercentage of participants (Number)
Group A (Low-dose)47
Group B (Standard-dose)54

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Mean Cumulative Prednisone Dose (mg/kg) Over 42 Days From the Start of Treatment

The total cumulative dose of prednisone (milligrams/kilogram) was calculated starting from the start of therapy through study day 42. (NCT00929695)
Timeframe: At day 42 after initiation of treatment

Interventionmilligrams per kilogram (Mean)
Grade IIa GVHD; 0.5 mg/kg/d Prednisone22.2
Grade IIa GVHD; 1.0 mg/kg/d Prednisone27.1
Grade IIb-IV GVHD; 1.0 mg/kg/d Prednisone38.4
Grade IIb-IV GVHD; 2.0 mg/kg/d Prednisone41.3

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Non-relapse Mortality

Non-relapse mortality (NRM) is defined as death due to any cause in the absence of documented relapse/progression. (NCT00929695)
Timeframe: At 12 months after the start of prednisone therapy

Interventionpercentage of participants (Number)
Group A (Low-dose)15
Group B (Standard-dose)16

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Overall Survival

Percentage of patients surviving as estimated by Kaplan-Meier. (NCT00929695)
Timeframe: At 12 months after the start of prednisone therapy

Interventionpercentage of participants (Number)
Group A (Low-dose)77
Group B (Standard-dose)77

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Prednisone-associated Toxicity as Assessed by Hypertension

The number of different anti-hypertensive medications administered to control hypertension were collected. The mean change in the number of medications from baseline to day 42 was measured. (NCT00929695)
Timeframe: Baseline and then through 42 days after starting treatment

Interventionmedications (Mean)
Group A (Low-dose)-0.29
Group B (Standard-dose)-0.24

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Prednisone-associated Toxicity as Assessed by Hyperglycemia

Impact on blood glucose (BG) control will be assessed by comparing average BG and BG-variability between patients given standard-dose and low-dose prednisone. (NCT00929695)
Timeframe: Baseline and then through 42 days after starting treatment

Interventionmg/dL (Mean)
Group A (Low-dose)140
Group B (Standard-dose)142

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Prednisone-associated Toxicity as Assessed by Invasive Infections (Bacterial, Fungal and Viral)

The total number of invasive infections (bacterial, fungal and viral) occurring in patients in each group were collected. (NCT00929695)
Timeframe: Baseline and through 100 days of treatment

Interventionpercentage of participants (Number)
Group A (Low-dose)52
Group B (Standard-dose)53

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Treatment Status (Success/Failure) of CD at the Third Follow-up Visit

"The signs and symptoms of CD were rated on PGA 5-point scale (range, 0 - 4 scale): 0 - no clinically relevant reaction; 1- macular erythema with induration; 2 - weak (non-vesicular) reaction with erythema, infiltration, and possible papules; 3 - strong (edematous or vesicular) reaction; 4 - extreme (spreading, bullous, ulcerative) reaction. Success was defined as a score of 0 or 1 and failure was defined as a score of 2, 3, or 4." (NCT00929981)
Timeframe: Third follow-up visit (between Day 6 to 10 after EOT)

InterventionPercentage of Participants (Number)
SuccessFailure
Medrol100.000

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Treatment Status (Success/Failure) of Contact Dermatitis (CD) at the Second Follow-up Visit

"The signs and symptoms of CD were rated on Physician's Global Assessment (PGA) 5-point scale (range, 0 - 4 scale): 0 - no clinically relevant reaction; 1- macular erythema with induration; 2 - weak (non-vesicular) reaction with erythema, infiltration, and possible papules; 3 - strong (edematous or vesicular) reaction; 4 - extreme (spreading, bullous, ulcerative) reaction. Success was defined as a score of 0 or 1 and failure was defined as a score of 2, 3, or 4." (NCT00929981)
Timeframe: Second follow-up visit (Day 5-28)

InterventionPercentage of Participants (Number)
SuccessFailure
Medrol93.86.30

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Change From Baseline in Participant-rated Clinical Severity Score of Lesions at First, Second, Third and Final Follow-up Visits

Participant-rated clinical severity score of lesions rated the severity of all symptoms in the past 24 hours on an 11-point Numerical Rating Scale (NRS) where 0 = No lesions and 10 = Most severe possible lesions. (NCT00929981)
Timeframe: Baseline,First Follow-up(between Day 6-10 of start of treatment),Second(Day 5-28),Third(between Day 6-10 after EOT),Final(between Day 25-35 after EOT)

InterventionUnits on a scale (Mean)
BaselineChange at first follow-upChange at second follow-upChange at third follow-upChange at final follow-up
Medrol6.8-4.1-6.2-6.7-6.8

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Change From Baseline in Participant-rated Pruritus Score at First, Second, Third and Final Follow-up Visits

Participant-rated pruritus score of lesions rated the severity of pruritus suffered in the past 24 hours on an 11-point NRS where 0 = no pruritus and 10 = most severe possible pruritus. (NCT00929981)
Timeframe: Baseline,First Follow-up(between Day 6-10 of start of treatment),Second(Day 5-28),Third(between Day 6-10 after EOT),Final(between Day 25-35 after EOT)

InterventionUnits on a scale (Mean)
BaselineChange at first follow-upChange at second follow-upChange at third follow-upChange at final follow-up
Medrol7.3-4.2-6.3-7.1-7.2

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Change From Baseline in Investigator-rated Total Signs and Symptoms of CD Score at First, Second, Third and Final Follow-up Visits

Investigator-rated total signs and symptoms score of CD included pruritus, erythema, induration, vesiculation, edema or other specific sign or symptom rated on a 5 point scale of 0 - 4 (0=none, 1=mild, 2=moderate, 3=severe, 4=extreme) with a total score of 0 - 20 (lower score was preferred). (NCT00929981)
Timeframe: Baseline,First Follow-up(between Day 6-10 of start of treatment),Second(Day 5-28),Third(between Day 6-10 after EOT),Final(between Day 25-35 after EOT)

InterventionUnits on a scale (Mean)
BaselineChange at first follow-upChange at second follow-upChange at third follow-upChange at final follow-up
Medrol9.2-5.6-8.3-9.0-9.1

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Treatment Status (Success/Failure) of CD at the Final Follow-up Visit

"The signs and symptoms of CD were rated on PGA 5-point scale (range, 0 - 4 scale): 0 - no clinically relevant reaction; 1- macular erythema with induration; 2 - weak (non-vesicular) reaction with erythema, infiltration, and possible papules; 3 - strong (edematous or vesicular) reaction; 4 - extreme (spreading, bullous, ulcerative) reaction. Success was defined as a score of 0 or 1 and failure was defined as a score of 2, 3, or 4." (NCT00929981)
Timeframe: Final follow-up visit (between Day 25 to 35 after EOT)

InterventionPercentage of Participants (Number)
SuccessFailure
Medrol100.000

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Treatment Status (Success/Failure) of CD at the First Follow-up Visit

"The signs and symptoms of CD were rated on PGA 5-point scale (range, 0 - 4 scale): 0 - no clinically relevant reaction; 1- macular erythema with induration; 2 - weak (non-vesicular) reaction with erythema, infiltration, and possible papules; 3 - strong (edematous or vesicular) reaction; 4 - extreme (spreading, bullous, ulcerative) reaction. Success was defined as a score of 0 or 1 and failure was defined as a score of 2, 3, or 4." (NCT00929981)
Timeframe: First follow-up visit (between Day 6 to 10 after start of treatment)

InterventionPercentage of Participants (Number)
SuccessFailure
Medrol52.5047.50

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Primary Endpoint: Number of Participants With Low Cardiac Output Syndrome (LCOS) or Death at 36 Hours From Admission to the Intensive Care Unit (ICU) After Surgery.

The presence of low cardiac output syndrome (LCOS) was defined by the same definition used in the PRIMACORP study (Hoffman TM.et.al. Circulation 2003 107:996-1002). Specifically, if there were clinical signs and symptoms of low cardiac output (e.g., tachycardia, oliguria, cold extremities, cardiac arrest, etc.) which required one or more of the following interventions: mechanical circulatory support, the escalation of existing pharmacological circulatory support to >100% over baseline, or the initiation of new pharmacological circulatory support. (NCT00934843)
Timeframe: 36 hours

Interventionparticipants (Number)
MP Single Dose17
MP Two Dose15

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Number of Participants Who Died Between 36 Hours and 30 Days Following Cardiac Surgery

Number of participants who died of any cause between 36 hours and 30 days following cardiac surgery (NCT00934843)
Timeframe: at 36 hours and 30 days

Interventionparticipants (Number)
MP Single Dose1
MP Two Dose0

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Inotropic Score

The inotropic score was calculated by the equation using drug dosages in micrograms/kg/min, (dopamine+dobutamine) + (milrinonex10) + (epinephrinex100) and recorded hourly upon arrival to the ICUthrough 36 hours postoperatively. The highest score during this timeframe was recorded. This score converts dosages of commonly used inotropic medications into a score. The higher the score the more inotropic medications required. The minimum score would be zero indicating no inotropic medications were used. There is no maximum score. (NCT00934843)
Timeframe: over the first 36 hours after surgery

InterventionScores on a scale (Mean)
MP Single Dose14.4
MP Two Dose15.0

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Total Intake/Output of Fluid

Total amount of all fluids in and out during the first 36 hours postoperatively in mL. (NCT00934843)
Timeframe: over 36 hours

,
InterventionmL (Mean)
Total Fluid in at 36 hrTotal Fluid out at 36 hr
MP Single Dose575600
MP Two Dose586558

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Urine Output

Total urine output in mL over the first 36 hours after cardiac surgery (NCT00934843)
Timeframe: over 36 hours

InterventionmL (Mean)
MP Single Dose498
MP Two Dose453

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Pain(at 6 Months): Nirschl Staging

"NIRSCHL STAGING:~phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps~No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain" (NCT00947765)
Timeframe: 6 months

InterventionUnits on a scale (Mean)
Autologous Blood Injection Group0.366
Local Corticosteroid Injection Group1.233

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Pain(at 4 Weeks): Visual Analogue Scale

"VISUAL ANALOGUE SCALE:~Pain of the participants will be assessed by most widely used and accepted visual analogue scale. It consists of a 10 centimeter line marked at one end with no pain and at other end with worst pain ever. Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between no pain to patients mark.~No pain____1 ___ 2 ___ 3 ___ 4 ___ 5 ___ 6 ___ 7 ___ 8 ___ 9 ___ 10 worst pain ever." (NCT00947765)
Timeframe: 4 weeks

InterventionUnits on a scale (Mean)
Autologous Blood Injection Group3.2
Local Corticosteroid Injection Group1.533

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Pain(at 12 Weeks): Visual Analogue Scale

"VISUAL ANALOGUE SCALE:~Pain of the participants will be assessed by most widely used and accepted visual analogue scale. It consists of a 10 centimeter line marked at one end with no pain and at other end with worst pain ever. Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between no pain to patients mark.~No pain____1 ___ 2 ___ 3 ___ 4 ___ 5 ___ 6 ___ 7 ___ 8 ___ 9 ___ 10 worst pain ever." (NCT00947765)
Timeframe: 12 weeks

InterventionUnits on a scale (Mean)
Autologous Blood Injection Group0.6
Local Corticosteroid Injection Group1.5

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Pain(at 12 Weeks): Nirschl Staging

"NIRSCHL STAGING:~phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps~No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain" (NCT00947765)
Timeframe: 12 weeks

InterventionUnits on a scale (Mean)
Autologous Blood Injection Group0.433
Local Corticosteroid Injection Group1.03

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Pain(at 1 Week): Nirschl Staging (0 to 7)

"NIRSCHL STAGING:~phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps~No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain" (NCT00947765)
Timeframe: 1 week

InterventionUnits on a scale (Mean)
Autologous Blood Injection Group5.1
Local Corticosteroid Injection Group3.06

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Pain (at 1 Week): Visual Analogue Scale(0 to 10)

"VISUAL ANALOGUE SCALE:~Pain of the participants will be assessed by most widely used and accepted visual analogue scale. It consists of a 10 centimeter line marked at one end with no pain and at other end with worst pain ever. Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between no pain to patients mark.~No pain____1___2___3___4___5___6___7___8___9___10 worst pain ever." (NCT00947765)
Timeframe: 1 week

InterventionUnits on a scale (Mean)
Autologous Blood Injection Group7.166
Local Corticosteroid Injection Group4.5

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Pain(at 4 Weeks): Nirschl Staging

"NIRSCHL STAGING:~phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps~No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain" (NCT00947765)
Timeframe: 4 weeks

InterventionUnits on a scale (Mean)
Autologous Blood Injection Group2.2
Local Corticosteroid Injection Group1.03

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Pain(at 6 Months): Visual Analogue Scale

"VISUAL ANALOGUE SCALE:~Pain of the participants will be assessed by most widely used and accepted visual analogue scale. It consists of a 10 centimeter line marked at one end with no pain and at other end with worst pain ever. Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between no pain to patients mark.~No pain____1 ___ 2 ___ 3 ___ 4 ___ 5 ___ 6 ___ 7 ___ 8 ___ 9 ___ 10 worst pain ever." (NCT00947765)
Timeframe: 6 months

InterventionUnits on a scale (Mean)
Autologous Blood Injection Group0.533
Local Corticosteroid Injection Group1.833

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Cortisol Measured on Treatment Day 1 (Baseline Study) BEFORE Exercise Protocol

Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL. (NCT00957801)
Timeframe: treatment day 1 - before exercise

Interventionug/dL (Mean)
Testosterone Injection7.25
Testosterone Gel6.00
Medrol 6 Day Dose Pack6.64
Testosterone Injection and Medrol 6 Day Dose Pack6.28

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Cortisol Measured on Treatment Day 8 (Post Study) AFTER Exercise Protocol

Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL. (NCT00957801)
Timeframe: treatment day 8 - after exercise

Interventionug/dL (Mean)
Testosterone Injection7.05
Testosterone Gel6.28
Medrol 6 Day Dose Pack4.40
Testosterone Injection and Medrol 6 Day Dose Pack5.78

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Cortisol Measured on Treatment Day 8 (Post Study) BEFORE Exercise Protocol

Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL. (NCT00957801)
Timeframe: treatment day 8 - before exercise

Interventionug/dL (Mean)
Testosterone Injection7.84
Testosterone Gel5.97
Medrol 6 Day Dose Pack6.28
Testosterone Injection and Medrol 6 Day Dose Pack5.19

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Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 1 (Baseline Study)

Dehydroepiandrosterone sulfate (DHEA-S) was measured before and after the treatment week on study treatment days 1 and 8. DHEA-S was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 28-290 ug/dL. (NCT00957801)
Timeframe: treatment day 1

Interventionug/dL (Mean)
Testosterone Injection46.34
Testosterone Gel34.16
Medrol 6 Day Dose Pack62.55
Testosterone Injection and Medrol 6 Day Dose Pack46.07

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Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 8 (Post Study)

Dehydroepiandrosterone sulfate (DHEA-S) was measured before and after the treatment week on study treatment days 1 and 8. DHEA-S was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 28-290 ug/dL. (NCT00957801)
Timeframe: treatment day 8

Interventionug/dL (Mean)
Testosterone Injection37.96
Testosterone Gel35.54
Medrol 6 Day Dose Pack34.74
Testosterone Injection and Medrol 6 Day Dose Pack36.07

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Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) During the Treatment Week

"The Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with 0 being no fatigue and 10 being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions.~This data is presented as the treatment week average of study days 1-8." (NCT00957801)
Timeframe: Study days 1-7 (treatment week)

Interventionunits on a scale (Mean)
Testosterone Injection1.84
Testosterone Gel1.79
Medrol 6 Day Dose Pack2.19
Testosterone Injection and Medrol 6 Day Dose Pack1.57

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Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) in the Pre-treatment Week

"The Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with 0 being no fatigue and 10 being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions.~This data is presented as the pre-treatment week average of study days -7 to -1." (NCT00957801)
Timeframe: Study days -7 to -1 (Pre - treatment)

Interventionunits on a scale (Mean)
Testosterone Injection2.25
Testosterone Gel1.47
Medrol 6 Day Dose Pack2.26
Testosterone Injection and Medrol 6 Day Dose Pack1.86

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Hematocrit Measured on Treatment Day 1 (Baseline Study)

Hematocrit was measured before and after treatment week (study treatment days 1 and 8). Hematocrit was analyzed by UTMB clinical laboratory. Normal ranges are 38.4% - 49.3%. (NCT00957801)
Timeframe: treatment day 1

Interventionpercent (Mean)
Testosterone Injection39.17
Testosterone Gel38.4
Medrol 6 Day Dose Pack40.45
Testosterone Injection and Medrol 6 Day Dose Pack39.86

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Hematocrit Measured on Treatment Day 8 (Post Study)

Hematocrit was measured before and after treatment week (study treatment days 1 and 8). Hematocrit was analyzed by UTMB clinical laboratory. Normal ranges are 38.4% - 49.3%. (NCT00957801)
Timeframe: treatment day 8

Interventionpercent (Mean)
Testosterone Injection38.74
Testosterone Gel37.23
Medrol 6 Day Dose Pack40.53
Testosterone Injection and Medrol 6 Day Dose Pack39.24

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C-Reactive Protein (CRP) Measured on Treatment Day 8 (Post Study)

C-Reactive Protein (CRP) was measured during the treatment week (study treatment days 1 and 8). CRP was analyzed by UTMB clinical laboratory. Normal ranges are 0.0 - 0.8 mg/dL. (NCT00957801)
Timeframe: treatment day 8

Interventionmg/dL (Mean)
Testosterone Injection0.47
Testosterone Gel0.31
Medrol 6 Day Dose Pack0.32
Testosterone Injection and Medrol 6 Day Dose Pack0.3

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High-Density Lipoproteins (HDL) Measured on Treatment Day 8 (Post Study)

High Density Lipoproteins (HDL) was measured before and after treatment week (study treatment days 1 and 8). HDL was analyzed by UTMB clinical laboratory. Normal ranges are higher than 35 mg/dL. (NCT00957801)
Timeframe: treatment day 8

Interventionmg/dL (Mean)
Testosterone Injection41.29
Testosterone Gel36.71
Medrol 6 Day Dose Pack47.67
Testosterone Injection and Medrol 6 Day Dose Pack43.43

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Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 1 (Baseline Study)

Insulin like growth factor 1 (IGF-1) was measured before and after the treatment week on study treatment days 1 and 8. IGF-1 was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 33-220 ng/mL. (NCT00957801)
Timeframe: treatment day 1

Interventionng/mL (Mean)
Testosterone Injection71.77
Testosterone Gel69.2
Medrol 6 Day Dose Pack61.42
Testosterone Injection and Medrol 6 Day Dose Pack90.74

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Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 8 (Post Study)

Insulin like growth factor 1 (IGF-1) was measured before and after the treatment week on study treatment days 1 and 8. IGF-1 was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 33-220 ng/mL. (NCT00957801)
Timeframe: treatment day 8

Interventionng/mL (Mean)
Testosterone Injection80.16
Testosterone Gel72.11
Medrol 6 Day Dose Pack69.17
Testosterone Injection and Medrol 6 Day Dose Pack54.86

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Insulin Measured on Treatment Day 1 (Baseline Study)

Insulin was measured before and after the treatment week on study treatment days 1 and 8. Insulin was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is less than 25 uIu/mL. (NCT00957801)
Timeframe: treatment day 1

InterventionuIu/mL (Mean)
Testosterone Injection8.53
Testosterone Gel10.28
Medrol 6 Day Dose Pack4.09
Testosterone Injection and Medrol 6 Day Dose Pack9.89

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Insulin Measured on Treatment Day 8 (Post Study)

Insulin was measured before and after the treatment week on study treatment days 1 and 8. Insulin was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is less than 25 uIu/mL. (NCT00957801)
Timeframe: treatment day 8

InterventionuIu/mL (Mean)
Testosterone Injection7.47
Testosterone Gel10.58
Medrol 6 Day Dose Pack3.92
Testosterone Injection and Medrol 6 Day Dose Pack3.89

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Low-Density Lipoproteins (LDL) Measured on Treatment Day 1 (Baseline Study)

Low Density Lipoproteins (LDL) was measured before and after treatment week (study treatment days 1 and 8). LDL was analyzed by UTMB clinical laboratory. Normal ranges are less than 160 mg/dL. (NCT00957801)
Timeframe: treatment day 1

Interventionmg/dL (Mean)
Testosterone Injection103.0
Testosterone Gel93.57
Medrol 6 Day Dose Pack96.83
Testosterone Injection and Medrol 6 Day Dose Pack90.71

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Low-Density Lipoproteins (LDL) Measured on Treatment Day 8 (Post Study)

Low Density Lipoproteins (LDL) was measured before and after treatment week (study treatment days 1 and 8). LDL was analyzed by UTMB clinical laboratory. Normal ranges are less than 160 mg/dL. (NCT00957801)
Timeframe: treatment day 8

Interventionmg/dL (Mean)
Testosterone Injection104.0
Testosterone Gel94.57
Medrol 6 Day Dose Pack87.5
Testosterone Injection and Medrol 6 Day Dose Pack75.14

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Cortisol Measured on Treatment Day 1 (Baseline Study) AFTER Exercise Protocol

Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL. (NCT00957801)
Timeframe: treatment day 1 - after exercise

Interventionug/dL (Mean)
Testosterone Injection7.71
Testosterone Gel7.20
Medrol 6 Day Dose Pack4.76
Testosterone Injection and Medrol 6 Day Dose Pack4.15

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Prostate Specific Antigen (PSA) Measured on Treatment Day 1 (Baseline Study)

Prostate Specific Antigen (PSA) was measured before and after treatment week (study treatment days 1 and 8). PSA was analyzed by UTMB clinical laboratory. Normal ranges are less than 4.0 ng/mL. (NCT00957801)
Timeframe: treatment day 1

Interventionng/mL (Mean)
Testosterone Injection1.92
Testosterone Gel2.33
Medrol 6 Day Dose Pack1.85
Testosterone Injection and Medrol 6 Day Dose Pack1.83

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Prostate Specific Antigen (PSA) Measured on Treatment Day 8 (Post Study)

Prostate Specific Antigen (PSA) was measured before and after treatment week (study treatment days 1 and 8). PSA was analyzed by UTMB clinical laboratory. Normal ranges are less than 4.0 ng/mL. (NCT00957801)
Timeframe: treatment day 8

Interventionng/mL (Mean)
Testosterone Injection1.98
Testosterone Gel2.32
Medrol 6 Day Dose Pack1.78
Testosterone Injection and Medrol 6 Day Dose Pack2.07

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Serum Estradiol Measured on Treatment Day 1 (Baseline Study)

Estradiol was measured during the treatment week (treatment days 1 and 8). Serum estradiol was analyzed by UTMB clinical laboratory. Normal ranges are 20-47 pg/mL. (NCT00957801)
Timeframe: treatment day 1

Interventionpg/mL (Mean)
Testosterone Injection22.86
Testosterone Gel33.69
Medrol 6 Day Dose Pack36.33
Testosterone Injection and Medrol 6 Day Dose Pack34.71

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Serum Estradiol Measured on Treatment Day 8 (Post Study)

Estradiol was measured during the treatment week (treatment days 1 and 8). Serum estradiol was analyzed by UTMB clinical laboratory. Normal ranges are 20-47 pg/mL. (NCT00957801)
Timeframe: treatment day 8

Interventionpg/mL (Mean)
Testosterone Injection48.29
Testosterone Gel33.43
Medrol 6 Day Dose Pack30.83
Testosterone Injection and Medrol 6 Day Dose Pack47.14

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Serum Total Testosterone Measured Before Treatment on Treatment Day 1 (Baseline Study)

"Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration." (NCT00957801)
Timeframe: treatment day 1

Interventionng/dL (Mean)
Testosterone Injection307.57
Testosterone Gel363.43
Medrol 6 Day Dose Pack408.17
Testosterone Injection and Medrol 6 Day Dose Pack318.68

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Serum Total Testosterone Measured on Treatment Day 2

"Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration." (NCT00957801)
Timeframe: treatment day 2

Interventionng/dL (Mean)
Testosterone Injection980.86
Testosterone Gel526.71
Medrol 6 Day Dose Pack191.87
Testosterone Injection and Medrol 6 Day Dose Pack675.86

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Serum Total Testosterone Measured on Treatment Day 3

"TTestosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration." (NCT00957801)
Timeframe: treatment day 3

Interventionng/dL (Mean)
Testosterone Injection828.71
Testosterone Gel527.43
Medrol 6 Day Dose Pack206.0
Testosterone Injection and Medrol 6 Day Dose Pack673.29

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Serum Total Testosterone Measured on Treatment Day 4

"Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration." (NCT00957801)
Timeframe: treatment day 4

Interventionng/dL (Mean)
Testosterone Injection779.57
Testosterone Gel441.71
Medrol 6 Day Dose Pack271.6
Testosterone Injection and Medrol 6 Day Dose Pack734.57

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Serum Total Testosterone Measured on Treatment Day 5

"TesTestosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration." (NCT00957801)
Timeframe: treatment day 5

Interventionng/dL (Mean)
Testosterone Injection722.0
Testosterone Gel460.14
Medrol 6 Day Dose Pack246.33
Testosterone Injection and Medrol 6 Day Dose Pack669.71

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Serum Total Testosterone Measured on Treatment Day 6

"Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration." (NCT00957801)
Timeframe: treatment day 6

Interventionng/dL (Mean)
Testosterone Injection629.0
Testosterone Gel536.43
Medrol 6 Day Dose Pack284.5
Testosterone Injection and Medrol 6 Day Dose Pack645.14

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Serum Total Testosterone Measured on Treatment Day 7

"Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration." (NCT00957801)
Timeframe: treatment day 7

Interventionng/dL (Mean)
Testosterone Injection578.29
Testosterone Gel485.86
Medrol 6 Day Dose Pack320.0
Testosterone Injection and Medrol 6 Day Dose Pack579.57

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Serum Total Testosterone Measured on Treatment Day 8 (Post Study)

"Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration." (NCT00957801)
Timeframe: treatment day 8

Interventionng/dL (Mean)
Testosterone Injection454.29
Testosterone Gel435.14
Medrol 6 Day Dose Pack340.17
Testosterone Injection and Medrol 6 Day Dose Pack481.14

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Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 1 (Baseline Study)

Sex Hormone Binding Globulin (SHBG) was measured before and after the treatment week on study treatment days 1 and 8. SHBG was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 10-57 nmol/L. (NCT00957801)
Timeframe: treatment day 1

Interventionnmol/L (Mean)
Testosterone Injection21.78
Testosterone Gel19.86
Medrol 6 Day Dose Pack25.66
Testosterone Injection and Medrol 6 Day Dose Pack24.70

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Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 8 (Post Study)

Sex Hormone Binding Globulin (SHBG) was measured before and after the treatment week on study treatment days 1 and 8. SHBG was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 10-57 nmol/L. (NCT00957801)
Timeframe: treatment day 8

Interventionnmol/L (Mean)
Testosterone Injection17.62
Testosterone Gel20.13
Medrol 6 Day Dose Pack19.22
Testosterone Injection and Medrol 6 Day Dose Pack14.57

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Total Cholesterol Measured on Treatment Day 1 (Baseline Study)

Total Cholesterol was measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 120-200 mg/dL. (NCT00957801)
Timeframe: treatment day 1

Interventionmg/dL (Mean)
Testosterone Injection171.29
Testosterone Gel165.57
Medrol 6 Day Dose Pack168.00
Testosterone Injection and Medrol 6 Day Dose Pack156.71

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Total Cholesterol Measured on Treatment Day 8 (Post Study)

Total Cholesterol was measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 120-200 mg/dL. (NCT00957801)
Timeframe: treatment day 8

Interventionmg/dL (Mean)
Testosterone Injection172
Testosterone Gel162.86
Medrol 6 Day Dose Pack166.17
Testosterone Injection and Medrol 6 Day Dose Pack141.86

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High-Density Lipoproteins (HDL) Measured on Treatment Day 1 (Baseline Study)

High Density Lipoproteins (HDL) was measured before and after treatment week (study treatment days 1 and 8). HDL was analyzed by UTMB clinical laboratory. Normal ranges are higher than 35 mg/dL. (NCT00957801)
Timeframe: treatment day 1

Interventionmg/dL (Mean)
Testosterone Injection40.29
Testosterone Gel38.86
Medrol 6 Day Dose Pack46.50
Testosterone Injection and Medrol 6 Day Dose Pack42.14

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Triglycerides Measured on Treatment Day 8 (Post Study)

Triglycerides were measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 30-170 mg/dL. (NCT00957801)
Timeframe: treatment day 8

Interventionmg/dL (Mean)
Testosterone Injection112.57
Testosterone Gel160.0
Medrol 6 Day Dose Pack155.17
Testosterone Injection and Medrol 6 Day Dose Pack116.28

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Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 1 (Baseline Study)

Very Low Density Lipoproteins (VLDL) was measured before and after treatment week (study treatment days 1 and 8). VLDL was analyzed by UTMB clinical laboratory. Normal ranges are 5-60 mg/dL. (NCT00957801)
Timeframe: treatment day 1

Interventionmg/dL (Mean)
Testosterone Injection28
Testosterone Gel33.14
Medrol 6 Day Dose Pack24.67
Testosterone Injection and Medrol 6 Day Dose Pack23.86

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Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 8 (Post Study)

Very Low Density Lipoproteins (VLDL) was measured before and after treatment week (study treatment days 1 and 8). VLDL was analyzed by UTMB clinical laboratory. Normal ranges are 5-60 mg/dL. (NCT00957801)
Timeframe: treatment day 8

Interventionmg/dL (Mean)
Testosterone Injection26.71
Testosterone Gel29.29
Medrol 6 Day Dose Pack31.0
Testosterone Injection and Medrol 6 Day Dose Pack24.71

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Triglycerides Measured on Treatment Day 1 (Baseline Study)

Triglycerides were measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 30-170 mg/dL. (NCT00957801)
Timeframe: treatment day 1

Interventionmg/dL (Mean)
Testosterone Injection140.42
Testosterone Gel164.0
Medrol 6 Day Dose Pack122.5
Testosterone Injection and Medrol 6 Day Dose Pack119.71

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C-Reactive Protein (CRP) Measured on Treatment Day 1 (Baseline Study)

C-Reactive Protein (CRP) was measured during the treatment week (study treatment days 1 and 8). CRP was analyzed by UTMB clinical laboratory. Normal ranges are 0.0 - 0.8 mg/dL. (NCT00957801)
Timeframe: treatment day 1

Interventionmg/dL (Mean)
Testosterone Injection0.47
Testosterone Gel0.33
Medrol 6 Day Dose Pack0.32
Testosterone Injection and Medrol 6 Day Dose Pack0.4

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Allergy/Immunology Adverse Events

Number of allergy/immunology AE per study arm (NCT00967226)
Timeframe: enrollment through study closeout or study withdrawal up to 9 months

InterventionAdverse Events (Number)
Allergy/Immunology Events Propranolol1
Allergy/Immunology Events Prednisolone1

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Growth and Development Adverse Events

Number of Growth and Development AEs in each study arm (NCT00967226)
Timeframe: enrollment to study withdrawal or close out up to 9 months

InterventionAdverse Events (Number)
Growth/Developoment AEs Propranolol0
Growth/Development AEs Prednisolone1

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Metabolic or Laboratory AEs

Number of Metabolic or Laboratory AEs in each study arm. (NCT00967226)
Timeframe: enrollment to study withdrawal or close out up to 9 months

InterventionAdverse Events (Number)
Metabolic/Laboratory AEs Propranolol1
Metabolic/Laboratory AEs Prednisolone0

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Infectious Adverse Events

Number of infectious AEs in each study arm (i.e. conjunctivitis, thrush, fever) (NCT00967226)
Timeframe: enrollment to study withdrawal or close out up to 9 months

InterventionAdverse Events (Number)
Infectious AEs Propranolol5
Infectious AEs Prednisolone3

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Gastrointestinal Adverse Events

Number of Gastrointestinal AEs in each arm (NCT00967226)
Timeframe: enrollment to study withdrawal or study close out up to 9 months

InterventionAdverse Events (Number)
Gastrointestinal AEs Propranolol6
Gastrointestinal AEs Prednisolone6

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Endocrinologic Adverse Events

Number of Endocrinologic AEs (of which adrenal crisis does not overlap). (NCT00967226)
Timeframe: enrollment to close out or study withdrawal up to 9 months

InterventionAdverse Events (Number)
Endocrine AEs Propranolol0
Endocrinologic AEs Prednisolone7

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Dermatologic Adverse Events

Number of Dermatologic Adverse Events in each study arm. (NCT00967226)
Timeframe: enrollment to study close out or withdrawal up to 9 months

InterventionAdverse Events (Number)
Dermatologic AEs Propranolol2
Dermatologic AEs Prednisolone1

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Decrease in Size of Hemangioma (Length x Width) in Square mm

A priori primary outcome was proportional change in the total surface area as measured by lesion's outer margin length x width at baseline minus the same measure at 4 months with surrogate data used at 5 months if 4 months not available. (NCT00967226)
Timeframe: 4-5 months after initiating therapy

Interventionmm squared (Mean)
Propranolol0.57
Prednisolone0.63

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Number of Serious Adverse Events (SAEs)

Number of serious adverse events experienced by the participants in each treatment arm within the categories adrenal crisis, growth/development, constitutional. Serious adverse events are defined as events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity, or result in a congenital anomaly/birth defect. Other important medical events, based upon appropriate medical judgment, may also be considered Serious Adverse Events if a trial participant's health is at risk and intervention is required to prevent an outcome mentioned. (NCT00967226)
Timeframe: enrollment until study close out or withdrawal up to 9 months

InterventionSerious Adverse Events (Number)
Number of Serious Adverse Events in Propranolol1
Number of Serious Adverse Events in Prednisolone11

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Vascular Adverse Events

Number of Vascular AEs in each study arm. (NCT00967226)
Timeframe: enrollment to study withdrawal or close out up to 9 months

InterventionAdverse Events (Number)
Vascular AEs Propranolol3
Vascular AEs Prednisolone4

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Pulmonary/Respiratory Adverse Events

Number of pulmonary/respiratory adverse events (CTCAE 22) in each study arm (NCT00967226)
Timeframe: enrollment through study close out or withdrawal, up to 9 months

InterventionAdverse Events (Number)
Pulmonary/Respiratory AEs Propranolol14
Pulmonary/Respiratory AEs Prednisolone4

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Tolerability of Medication

All adverse events relating to medication tolerability including: adrenal crisis, growth/development, constitutional (dehydration), allergy/immunology, dermatologic, endocrine, GI, infection, metabolism/labs, pulmonary, vascular. (NCT00967226)
Timeframe: enrollment until study close out or withdrawal up to 9 months

,
InterventionEvents (Number)
Adverse EventsSerious Adverse Events
Overall Number of Adverse Events in Prednisolone3011
Overall Number of Adverse Events in Propranolol341

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Constitutional Adverse Events

Number of constitutional AEs in each study arm. (NCT00967226)
Timeframe: enrollment to study close out or withdrawal up to 9 months

InterventionAdverse Events (Number)
Constitutional AEs Propranolol2
Constitutional AEs Prednisolone3

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Maximum Tolerated Dose [MTD] Determination by Number of Participants With Dose Limiting Toxicity (DLT)

"The Maximum tolerated dose (MTD) was the highest dose level at which fewer than 2 of 6 patients developed a dose limiting toxicity (DLT) in the first two cycles of therapy. A 3 by 3 design was used for dose escalation in the phase I portion of the study.~A dose-limiting toxic effect (DLT) was defined as a clinically significant adverse event or abnormal laboratory value directly attributable to everolimus and assessed as unrelated to disease progression, intercurrent illness, or concomitant medications, occurring during the first or second cycle of therapy, that met any of the following criteria: CTCAE version 3.0 grade 3 increased AST or ALT for 7 days, CTCAE grade 4 increased AST or ALT of any duration, or any other clinically significant CTCAE grade 3 or 4 toxic effect. Electrolyte abnormalities (changes in glucose, chemistries, liver enzymes, pancreatic enzymes) correctable by optimal therapy and without clinical impact were not considered DLTs." (NCT00968253)
Timeframe: Following first two dose cycles (21 days/each), up to 42 days

InterventionParticipants (Count of Participants)
Phase I: RAD001 5 mg + Combination Chemo0
Phase I: RAD001 10 mg + Combination Chemo1

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Overall Response Rate (OR) Where OR = CR + CRp + CRi

Number of participants out of total treated who experienced a complete response response according to RECIST criteria either (CR + CRp) CR Without Platelet Recovery. Response (CR + CRp) defined as Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x10^9/L, platelet count > 100 x10^9/L, and blasts < 5% in a normocellular or hypercellular marrow. Complete remission without platelet recovery (CRp): Peripheral blood and marrow parameters as for CR, but with platelet count > 20 x 10^9/L and < 100 x 10^9/L in the absence of platelet transfusions. CR with incomplete blood count recovery (CRi): Same as CR but platelets ≤ 100,000/mcl and/or neutrophils ≤ 1,000/mcl. (NCT00968253)
Timeframe: 8 courses of treatment, up to 24 weeks

Interventionpercentage of participants (Number)
Phase I: RAD001 5 mg + Combination Chemo33
Phase I: RAD001 10 mg + Combination Chemo33
Phase II: MTD RAD001 + Combination Chemo33

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Participant Responses by Daily Dose Level Assignment (RAD001 5 mg, 10 mg and MTD 5 mg)

Response defined as Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x10^9/L, platelet count > 100 x10^9/L, and blasts < 5% in a normocellular or hypercellular marrow. Complete remission without platelet recovery (CRp): Peripheral blood and marrow parameters as for CR, but with platelet count > 20 x 10^9/L and < 100 x 10^9/L in the absence of platelet transfusions. CR with incomplete blood count recovery (CRi): Same as CR but platelets ≤ 100,000/mcl and/or neutrophils ≤ 1,000/mcl. Partial remission (PR): Peripheral blood count recovery as for CR, with decrease in marrow blasts by > 50% from pretreatment values with no more than 25% leukemia/lymphoma cells in the marrow. Nonresponder, Other: All other responses will be considered failures. (NCT00968253)
Timeframe: Up to 20 cycles of study drugs (21 day cycles) or till disease progression

,,
Interventionparticipants (Number)
Complete RemissionComplete Remission without platelet recoveryCR with incomplete blood count recoveryPartial RemissionNonresponder
Phase I: RAD001 10 mg + Combination Chemo20115
Phase I: RAD001 5 mg + Combination Chemo10011
Phase II: MTD RAD001 + Combination Chemo31008

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Change in Bone Density (in Participants Untreated With Bisphosphonates)

Bone mineral density test was performed using x-ray radiation and the values of bone density were provided directly by the apparatus as grams per square centimeter (g/cm^2) . T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis. (NCT01000610)
Timeframe: Screening and Week 84

Interventiont-score (Number)
ScreeningWeek 84
Rituximab-1.82-1.6

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Number of Participants Reporting Adverse Events (AEs)

(NCT01000610)
Timeframe: Days 1 and 15, every 8 weeks up to Week 24 and and then every 3 months up to 18 months for a total of 104 weeks

Interventionnumber of participants (Number)
Participants who experienced an AEParticipants who experienced more than 1 AE
Rituximab117

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Percentage Change in Disease Activity Score 28 (DAS28) From Baseline to Week 24

The DAS28 score is a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], participant's global assessment of disease activity [visual analog scale: [VAS] 0 equals (=) no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to 10. Scores less than (<) 2.6 indicate best disease control and scores greater than or equal to (≥) 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6. The average improvement at each visit to the group score is equal to the formula (Previous DAS28 minus [-] current DAS 28)/ Previous DAS 28 x 100. Negative percentages indicate that the participant has worsened in comparison to last evaluation, and positive percentages indicate improvement of its DAS28 score and correlated with a bettering of clinical situation. (NCT01000610)
Timeframe: Baseline and Week 24

Interventionpercentage change from baseline (Mean)
Rituximab-1.7

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Percentage of Participants Whose DAS28 Improved by >1.2 at Week 24

The DAS28 score is a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], participant's global assessment of disease activity [VAS: 0 = no disease activity to 100 = maximum disease activity] and the ESR for a total possible score of 0 to 10. Scores < 2.6 indicate best disease control and scores ≥ 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6. An improvement of >1.2 was considered to be clinically significant improvement. (NCT01000610)
Timeframe: Baseline and Week 24

Interventionpercentage of participants (Number)
Rituximab75.0

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Percent Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24

Estimated Glomerular Filtration Rate (eGFR) was calculated using the Modification of Diet in Renal Disease (MDRD) formula. (NCT01085097)
Timeframe: Baseline, Week 24

Interventionpercent change (Mean)
Placebo12.1
Laquinimod 0.5 mg18.0
Laquinimod 1 mg24.3

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Number of Participants With Adverse Events (AEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'. (NCT01085097)
Timeframe: Baseline up to Week 28

Interventionparticipants (Number)
Placebo14
Laquinimod 0.5 mg15
Laquinimod 1 mg15

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Disease Free

Number of participants that were disease free (NCT01093586)
Timeframe: At 1 year

InterventionParticipants (Count of Participants)
Arm I4

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Recurrence or Relapse

Number of subjects that had disease recurrence (NCT01093586)
Timeframe: two years post transplant

InterventionParticipants (Count of Participants)
Arm I2

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Recurrence or Relapse

Number of subjects that had disease recurrence (NCT01093586)
Timeframe: one year in patients post UCBT

InterventionParticipants (Count of Participants)
Arm I2

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Overall Survival

Number of participants that were alive. (NCT01093586)
Timeframe: At 2 years

InterventionParticipants (Count of Participants)
Arm I4

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Overall Survival

Number of participants that were alive. (NCT01093586)
Timeframe: At 1 year

InterventionParticipants (Count of Participants)
Arm I6

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Overall Survival

Number of participants alive at 180 days post engraftment. (NCT01093586)
Timeframe: On day +180

InterventionParticipants (Count of Participants)
Arm I8

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Occurrence of Serious Infections

Number of participants that had infections (NCT01093586)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Arm I13

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Incidence of Chronic GVHD

Number of participants that have chronic GVHD. Chronic GVHD will be diagnosed and graded on clinical and histological criteria from the Center for International Blood and Marrow Transplant Research (CIBMTR) (NCT01093586)
Timeframe: At 1 year

InterventionParticipants (Count of Participants)
Arm I1

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Incidence of Acute Graft-versus-host Disease (GVHD)

Number of participants that had acute GVHD (NCT01093586)
Timeframe: At 100 days

InterventionParticipants (Count of Participants)
Arm I11

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Disease Free

Number of participants that were disease free (NCT01093586)
Timeframe: At 2 years

InterventionParticipants (Count of Participants)
Arm I4

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Hematologic Engraftment

Number of participants that were able to complete engraftment by day 42. (NCT01093586)
Timeframe: On day +42

InterventionParticipants (Count of Participants)
Arm I10

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Response Rate

Response includes Complete Response (CR), Partial Response (PR), and Stable Disease (SD) as defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v.1.1) for target lesions and assessed by CT or MRI. Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease. (NCT01105650)
Timeframe: Month 3

Interventionparticipants (Number)
Arm 1: CsA1
Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-22
Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-24

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Time to Disease Progression

Time from study entry until progressive disease or data collection cutoff. (NCT01105650)
Timeframe: 1 Year

Interventiondays (Median)
Arm 1: CsA52
Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-298
Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2100

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Overall Survival

Number of participants alive at 1 year. (NCT01105650)
Timeframe: 1 Year

Interventionparticipants (Number)
Arm 1: CsA0
Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-21
Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-23

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Number of Participants With Progressive Disease at One Year

(NCT01105650)
Timeframe: 1 Year

InterventionParticipants (Count of Participants)
Arm 1: CsA2
Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-21
Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-25

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Number of Participants With an Epstein Barr Virus (EBV) Viral Load Abnormalities Meeting the Criteria for PCC

The PCC range for EBV viral load was > 10,000 copies of deoxyribonucleic acid (DNA) per million lymphocytes. The assessments were done at Week 2, Week 4, Week 8 and Week 12. (NCT01114503)
Timeframe: Week 2 to Week 12

InterventionParticipants (Number)
Otelixizumab Cohort A10

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Number of Participants With Electrocardiogram (ECG) Abnormalities Meeting the Criteria for PCC

ECG parameters included pulse rate (PR) interval, QRS interval, QT interval, corrected QT interval using Bazett's formula (QTcB) and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval <110 and >220 milliseconds (msec); QRS interval <75 and >110 msec; QTc interval >480 to <= 500 msec, increase from baseline QTc >30 to <= 60 msec. (NCT01114503)
Timeframe: Screening (Day -35 to Day -1)

InterventionParticipants (Number)
Otelixizumab Cohort A10

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Number of Participants With Laboratory Clinical Chemistry Abnormalities Meeting the Criteria for Potential Clinical Concern (PCC)

The PCC range for clinical chemistry parameters included albumin, <30 gram per liter (g/L); calcium, low- < 2.0 millimole (mmol)/L: high->2.75 mmol/L; creatinine, high- > 1.3x ULN mmol/L or > 159 micromole (μmol)/L or > 44 μmol/L change from Baseline; glucose, low- < 3.0 mmol/L, high- > 9.0 0 mmol/L; magnesium, low- < 0.5 mmol/L, high- > 1.23 mmol/L, phosphorus, low- < 0.8 mmol/L, high- > 1.6 mmol/L; potassium, Low- < 3.0 mmol/L, high- > 5.5 mmol/L; sodium, low- < 130 mmol/L, high- > 150 mmol/L; bicarbonate, low- < 18 mmol/L, high- > 32 mmol/L; alanine aminotransferase, high->= 2x ULN, where the normal range was (NR) 0 - 39 international units (IU)/L; aspartate aminotransferase, high- >= 2x ULN, where NR was 0 - 39 IU/L; alkaline phosphatase, high- >= 1.5x ULN, where NR was 35 - 120 IU/L; total bilirubin- >= 1.5x ULN, where NR was 0 - 18 μmol/L.The assessments were done at Day 1 (pre dose), Day 8, Week 2-24 and Month 12 and 24. (NCT01114503)
Timeframe: Up to Month 24 (Long term follow-up)

InterventionParticipants (Number)
Otelixizumab Cohort A10

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Number of Participants With Laboratory Hematology Abnormalities Meeting the Criteria for PCC

The PCC range for hematology parameters included white blood cell count, low- < 3 giga cells (GI)/L, high- > 20 GI/L; neutrophil count, low- < 1.5 GI/L; hemoglobin, low- > 25 g/L change from baseline, high- 180 g/L; hematocrit, low- > 0.075 L change from baseline, high- 0.54 L; platelet count, low- < 100 GI/L, high- >550 GI/L and lymphocytes, low < 0.8 GI/L. The assessments were done at Day 1 (pre dose), Day 8, Week 2-24, Month 12 and 24. (NCT01114503)
Timeframe: Upto Month 24 (Long term follow-up)

InterventionParticipants (Number)
Otelixizumab Cohort A10

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Number of Participants With Laboratory Urinalysis Abnormalities Meeting the Criteria for PCC

The urinalysis parameters included pH, glucose, protein, blood and ketones by dipstic and microscopy (if urine dipstick was positive for blood or protein). The assessments were done at Day 1 (pre dose), Day 8, Week 2-24, Month 12 and 24. (NCT01114503)
Timeframe: Up to Month 24 (Long term follow-up)

InterventionParticipants (Number)
Otelixizumab Cohort A10

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Number of Participants With Thyroid Function Assessment, Hormone and Glucose Assay Abnormalities Meeting the Criteria for PCC

The following laboratory parameters were analyzed: thyroid function assessment (thyroid stimulating hormone [TSH], thyroid peroxidase antibody, thyrotropin receptor antibodies (TSH-R-Abs) or TSH-binding inhibiting immunoglobulin (TBII), free thyroxine [fT4], free triiodothyronine [fT3]; hormone and glucose assays (cortisol, adrenocorticotrophic hormone [ACTH], insulin-like growth factor [IgF-1] and plasma glucose. Thyroid function tests were done at Day 1 (pre-dose) and Week 4-24. Hormone and glucose assays were done at Day 1 (pre-dose) and Week 2-24. (NCT01114503)
Timeframe: Up to Week 24

InterventionParticipants (Number)
Otelixizumab Cohort A10

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Number of Participants With Vital Signs Abnormalities Meeting the Criteria for PCC

Vital signs assessment included pulse rate, blood pressure, temperature and respiratory rate. Criteria for vital sign values meeting potential clinical concern included: supine pulse rate <40 or >110 beats per minute (bpm), >= 15 increase from baseline and >= 30 decrease from baseline; systolic blood pressure (SBP) < 85 and > 160 millimeters of mercury (mm Hg), >= 20 mmHg increase from baseline and >= 40 mmHg decrease from baseline; diastolic blood pressure (DBP) < 45 and > 100 mm Hg, >= 10 mmHg increase from baseline and >= 20 mmHg decrease from baseline. (NCT01114503)
Timeframe: Up to Month 24 (Long term follow-up)

InterventionParticipants (Number)
Otelixizumab Cohort A10

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Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation

Lacrimation was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Excessive lacrimation (tear production and secretion, 1-3) is a symptom of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 31 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 3Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2Month 3: Grade 3
DUREZOL64.130.85.10.094.95.10.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0
PRED FORTE72.522.55.00.097.52.50.00.095.05.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0

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Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia

Photophobia was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Photophobia (abnormal intolerance to visual perception of light) is a symptom of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 31 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 3Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2Month 3: Grade 3
DUREZOL71.820.57.70.089.710.30.00.097.42.60.00.097.42.60.00.0100.00.00.00.0100.00.00.00.0
PRED FORTE60.035.05.00.087.510.02.50.095.05.00.00.092.55.00.02.597.52.50.00.0100.00.00.00.0

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Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity

Wound integrity was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Lack of wound integrity (healing, 1-3) is a sign of inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 31 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 3Month 1: Grade 0Month 1: Grade 1Month 1: Grade 2Month 1: Grade 3
DUREZOL100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0
PRED FORTE100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0

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Global Assessment Score of Postoperative Inflammation by Visit

A Global Assessment Score (GAS) was assigned by the Investigator based on the clinical evidence of postoperative inflammation: 0=clear, 1=improving satisfactorily; 2=not improving or worsening, withdrawal from study indicated to allow appropriate alternative therapy to be instituted. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 29: Grade 0Day 29: Grade 1Day 29: Grade 21 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 2Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2
DUREZOL30.869.20.048.748.72.656.443.60.079.520.50.089.77.72.692.35.12.6
PRED FORTE17.582.50.025.070.05.050.050.00.072.525.02.590.07.52.592.57.50.0

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Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection

Ciliary/limbal injection was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Ciliary/limbal injection (redness of the white sclera of the eye near the limbal ring) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 31 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 3Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2Month 3: Grade 3
DUREZOL69.228.20.02.689.710.30.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0
PRED FORTE57.540.02.50.090.010.00.00.0100.00.00.00.097.52.50.00.0100.00.00.00.0100.00.00.00.0

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Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis

Vitritis was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Vitritis (accumulation of inflammatory cells or exudates in the vitreous humor, the fluid that fills the middle chamber of the eye) is a sign of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 31 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 3Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2Month 3: Grade 3
DUREZOL100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0
PRED FORTE97.52.50.00.097.50.02.50.097.50.02.50.097.50.02.50.097.50.02.50.097.50.02.50.0

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Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade

Anterior chamber cell grade was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 5-point scale: Grade 0=0 cells; Grade 1=1 to 10 cells; Grade 2=11 to 20 cells; Grade 3=21 to 50 cells; Grade 4=>50 cells. The presence of blood cells (red and white) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 1: Grade 4Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 8: Grade 4Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 15: Grade 4Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 3Day 29: Grade 41 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 31 Week After Last Dose: Grade 4Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2Month 3: Grade 3Month 3: Grade 4
DUREZOL23.757.915.82.60.055.336.85.32.60.078.918.40.02.60.089.510.50.00.00.097.42.60.00.00.094.75.30.00.00.0
PRED FORTE40.030.027.50.02.557.532.510.00.00.077.517.55.00.00.095.02.52.50.00.095.02.52.50.00.097.50.02.50.00.0

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Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade

Anterior chamber flare was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. The presence of flare (increased protein levels) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 31 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 3Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2Month 3: Grade 3
DUREZOL41.051.37.70.061.535.92.60.074.417.97.70.087.212.80.00.094.92.62.60.092.35.12.60.0
PRED FORTE45.037.512.55.052.540.05.02.570.027.52.50.092.57.50.00.092.57.50.00.095.05.00.00.0

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Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis

Chemosis was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Chemosis (swelling of the conjunctiva) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 31 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 3Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2Month 3: Grade 3
DUREZOL82.115.40.02.697.42.60.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0
PRED FORTE85.015.00.00.0100.00.00.00.097.52.50.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0

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Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection

Conjunctival injection was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Conjunctival injection (redness of the white sclera of the eye) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 31 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 3Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2Month 3: Grade 3
DUREZOL46.248.72.62.679.520.50.00.089.710.30.00.097.42.60.00.0100.00.00.00.0100.00.00.00.0
PRED FORTE25.065.010.00.077.522.50.00.092.57.50.00.095.05.00.00.0100.00.00.00.0100.00.00.00.0

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Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity

Corneal clarity was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Lack of corneal clarity (1-3) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 31 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 3Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2Month 3: Grade 3
DUREZOL92.37.70.00.094.95.10.00.094.95.10.00.097.42.60.00.0100.00.00.00.0100.00.00.00.0
PRED FORTE87.512.50.00.090.07.52.50.090.010.00.00.097.52.50.00.097.52.50.00.097.52.50.00.0

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Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon

Hypopyon was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Hypopyon (pus in the anterior chamber of the eye) is a sign of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 31 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 3Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2Month 3: Grade 3
DUREZOL100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0
PRED FORTE100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0

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Percentage of Patients With an Anterior Cell Grade of 0 (no Cells) at Day 15 ± 2 Days

Anterior cell grade was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 5-point scale: Grade 0=0 cells; Grade 1=1 to 10 cells; Grade 2=11 to 20 cells; Grade 3=21 to 50 cells; Grade 4=>50 cells. The presence of blood cells (red and white) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. (NCT01124045)
Timeframe: Day 15 ± 2 days

InterventionPercentage of patients (Number)
DUREZOL78.9
PRED FORTE77.5

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Change in Serum SAA Levels Day 0 to Day 56

Serum Amyloid A (NCT01144143)
Timeframe: Day 0 to Day 56

Interventionug/ml (Mean)
Infliximab-1.0
Salt Water-715.6
Methylprednisolone Acetate-1580.2

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Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score Target Knee

The WOMAC questionnaire is used to evaluate the condition of patients with osteoarthritis. Patients answer questions based on how they are feeling. The questionnaire has a total of 24 questions which deal with pain, stiffness and physical function. Participants are asked to respond to how difficult it is for them to do/complete an activity. There is a total possible score of 96. A score of 0 equals no difficulty completing any of the 24 activities. A score of 96 would indicate extreme difficulty with all activities. (NCT01144143)
Timeframe: Change from Day 0 to Day 56

Interventionunits on a scale (Mean)
Infliximab-25.9
Normal Saline-9.3
Methylprednisolone Acetate2.0

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Change in Joint Effusions From Day 0 to Day 56 Target Knee

"Outcome calculated based on Physician observation of joint swelling from 0-3. A score of 0 = no effusion,1 = positive bulge, 2 = moderate effusion, 3 = tense effusion. The outcome represents the change in means between the two time points." (NCT01144143)
Timeframe: Change from Day 0 to Day 56

Interventionunits on a scale (Mean)
Infliximab0.3
Salt Water0.0
Methylprednisolone Acetate0.0

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Change in Levels of Serum IL-6

(NCT01144143)
Timeframe: Change from Day 0 to Day 56

Interventionpg/ml (Mean)
Infliximab-0.4
Salt Water8.1
Methylprednisolone Acetate5.5

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Change in Serum CRP Day 0 to Day 56

Serum measure of systemic inflammation (NCT01144143)
Timeframe: Day 0 to Day 56

Interventionmg/dl (Mean)
Infliximab-0.18
Salt Water-0.15
Methylprednisolone Acetate0.08

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Proportion of Subjects Who Discontinued Due to Lack of Efficacy

Lack of efficacy was defined as those subjects who discontinued study participation either due to treatment failure or an adverse event with a preferred term of iridocyclitis, iritis, uveitis, or vitritis. Proportion is reported as percentage of subjects. (NCT01201798)
Timeframe: Time to Event

InterventionPercentage of subjects (Number)
Durezol0
Pred Forte14.9

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Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14

Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = > 50 cell count. (NCT01201798)
Timeframe: Baseline (Day 0), Day 3, Day 7, Day 21, Day 28, Day 35, Day 42

,
InterventionUnits on a scale (Mean)
Baseline (Day 0)Day 3Day 7Day 21Day 28Day 35Day 42
Durezol2.6-1.1-1.8-2.4-2.3-2.3-2.3
Pred Forte2.6-1.0-1.6-2.1-2.1-2.1-2.1

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Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0

Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and recorded based on actual cell count. Anterior chamber flare (protein escaping from dialated vessels) was assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = none; 1 = mild (trace to clearly noticeable, visible); 2 = moderate; 3 = marked; and 4 = severe. Proportion is reported as percentage of subjects. (NCT01201798)
Timeframe: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

,
InterventionPercentage of subjects (Number)
Day 3Day 7Day 14Day 21Day 28Day 35Day 42
Durezol13.041.378.382.680.482.680.4
Pred Forte14.940.461.776.676.676.678.7

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Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14

Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = > 50 cell count. (NCT01201798)
Timeframe: Baseline (Day 0), Day 14

,
InterventionUnits on a scale (Mean)
Baseline (Day 0)Day 14
Durezol2.6-2.2
Pred Forte2.6-2.0

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Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points

The following symptoms were each graded by the subject according to a 0-100 visual analog scale (VAS) using a mark on a 100 mm line (0 = absent, 100 = maximal): eye pain, photophobia, blurred vision, and lacrimation. The total symptom score was calculated as the sum of the 4 individual symptom scores. (NCT01201798)
Timeframe: Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

,
InterventionUnits on a scale (Mean)
Baseline (Day 0)Day 3Day 7Day 14Day 21Day 28Day 35Day 42
Durezol186.7-88.4-108.2-133.3-138.8-140.1-143.9-146.2
Pred Forte203.2-88.4-123.8-137.4-149.5-152.4-147.3-155.5

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Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points

Anterior chamber flare (protein escaping from dialated vessels) was assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = none; 1 = mild (trace to clearly noticeable, visible); 2 = moderate; 3 = marked; and 4 = severe. (NCT01201798)
Timeframe: Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

,
InterventionUnits on a scale (Mean)
Baseline (Day 0)Day 3Day 7Day 14Day 21Day 28Day 35Day 42
Durezol2.2-1.1-1.6-2.0-2.0-2.0-2.0-2.0
Pred Forte2.3-1.2-1.6-1.9-2.0-2.0-2.0-2.0

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Proportion of Subjects With Anterior Chamber Cell Count of 0

Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and recorded based on actual cell count. Proportion is reported as a percentage of subjects. (NCT01201798)
Timeframe: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

,
InterventionPercentage of subjects (Number)
Day 3Day 7Day 14Day 21Day 28Day 35Day 42
Durezol13.021.752.273.973.969.669.6
Pred Forte2.121.338.348.963.863.868.1

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Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits

The following signs were each graded on a 0 - 3 scale (0 = absent; 1 = mild; 2 = moderate; 3 = severe): posterior synechia, hypopyon, limbal injection, and keratic precipitates. Peripheral synechia was graded by the combined number of clock hours affected (0 = absent; 1 = < 3 hrs; 2 = 3-6 hours; 3 = > 6 hours). The total sign score was calculated as the sum of the 5 individual sign scores, the anterior chamber cell grade and the anterior chamber flare grade. The minimum/best total sign score was 0, and the maximum/worst total sign score was 23. (NCT01201798)
Timeframe: Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

,
InterventionUnits on a scale (Mean)
Baseline (Day 0)Day 3Day 7Day 14Day 21Day 28Day 35Day 42
Durezol7.1-3.5-5.2-6.1-6.5-6.4-6.3-6.2
Pred Forte7.3-3.6-5.0-5.8-6.2-6.2-6.2-6.3

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Proportion of Subjects With Anterior Chamber Cell Grade ≤1

As assessed by the investigator during slit lamp examination. Anterior chamber cell grade was graded on a 5-point scale, with 0 = no cells; 1 = 1 to 10 cells; 2 = 11 to 20 cells; 3 = 21 to 50 cells; and 4 = more than 50 cells. Proportion is reported as percentage of subjects. (NCT01201798)
Timeframe: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

,
InterventionPercentage of subjects (Number)
Day 3Day 7Day 14Day 21Day 28Day 35Day 42
Durezol50.087.093.593.593.593.591.3
Pred Forte57.480.985.189.487.285.185.1

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Proportion of Subjects With Anterior Chamber Cell Grade of 0

Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = > 50 cell count. Proportion is reported as percentage of subjects. (NCT01201798)
Timeframe: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

,
InterventionPercentage of subjects (Number)
Day 3Day 7Day 14Day 21Day 28Day 35Day 42
Durezol15.234.865.284.880.478.376.1
Pred Forte6.425.555.363.870.270.274.5

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Number of Participants Who Survived at 6 Months Following Completion of Plasma Exchange (PLEX)

Following the completion of rapid removal of natalizumab using PLEX or equivalent. (NCT01211665)
Timeframe: 6 months

Interventionparticipants (Number)
Pulsed IVMP1
IVMP With Oral Prednisolone Taper1

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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

AE=any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. (NCT01211665)
Timeframe: from the first dose of study treatment through the end of the treatment period (6 months) + a 4-week post-treatment period

,
Interventionparticipants (Number)
AEsSAEs
IVMP With Oral Prednisolone Taper11
Pulsed IVMP22

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Severity of AEs and SAEs

AEs and SAEs were categorized as mild, moderate or severe according to the following criteria: Mild=barely noticeable to participant or does not make participant uncomfortable; does not influence performance or functioning; prescription drug not ordinarily needed for relief of symptom(s) but may be given because of personality of participant. Moderate=of a sufficient severity to make participant uncomfortable; performance of daily activity is influenced; participant is able to continue in study; treatment for symptom(s) may be needed. Severe=symptoms cause severe discomfort; symptoms cause incapacity or significant impact on participant's daily life; severity may cause cessation of treatment with study treatment; treatment for symptom(s) may be given and/or participant hospitalized. Please see Outcome Measure 3 for AE and SAE definitions. (NCT01211665)
Timeframe: from the first dose of study treatment through the end of the treatment period (6 months) + a 4-week post-treatment period

,
Interventionevents (Number)
Mild SAEModerate SAESevere SAEMild AEModerate AESevere AE
IVMP With Oral Prednisolone Taper110510
Pulsed IVMP112330

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Median Dose of Tocilizumab During the Noninterventional Phase

(NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionmg/kg (Median)
Tocilizumab8.0

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Median Time Interval Between V1 and V2

The noninterventional phase was planned to last for a maximum of 6 months per participant. The time between V1 and V2 was measured in months. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionmonths (Median)
Tocilizumab2.3

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Number of Participants With Changes in Tocilizumab Dose During the Noninterventional Phase

The dose of tocilizumab could have been reduced from the recommended 8 mg/kg to 4 mg/kg in participants in the case of adverse events. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionparticipants (Number)
Tocilizumab1

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Number of Participants With GC Switches During the Noninterventional Phase

During the noninterventional phase of the study, once LDA was achieved, GC was switched to MP tablets. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionparticipants (Number)
Tocilizumab0

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Percentage of Participants Able to Acheive LDA Assessed Using DAS28 While Receiving Oral GC on Background Tocilizumab Treatment During the Noninterventional Phase

DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the CRP and Patient's Global Assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 and oral GC intake with MP equivalent dose of ≥1 mg and ≤20 mg/day= LDA. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionpercentage of participants (Number)
Tocilizumab72.1

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Percentage of Participants Able to Discontinue GCs During the Interventional Phase by V9

(NCT01219933)
Timeframe: V9 (24 weeks after V3)

Interventionpercentage of participants (Number)
Tocilizumab3.3

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Percentage of Participants Able to Reduce Oral GCs by ≥50 Percent (%) During the Interventional Phase by V9

(NCT01219933)
Timeframe: V9 (24 weeks after V3)

Interventionpercentage of participants (Number)
Tocilizumab93.3

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Percentage of Participants Acheiving Remission Assessed Using DAS28 While Receiving Oral GC on Background TocilizumabTreatment During the Noninterventional Phase

DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the CRP and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <2.6 = remission. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionpercentage of participants (Number)
Tocilizumab41.2

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Percentage of Participants Able to Start the GC Reduction Phase at V3

All participants who maintained LDA (defined as DAS28-CRP ≤3.2) from V2 to V3 were included in the interventional phase for reduction of GC. (NCT01219933)
Timeframe: V3 (7 months)

Interventionpercentage of participants (Number)
Tocilizumab87.8

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Percentage of Participants in the Interventional Phase Who Achieved LDA and Discontinued Oral GC Within 20 Weeks

The percentage of participants with rheumatoid arthritis (RA) with LDA was defined as DAS28 ≤3.2, able to discontinue oral GC within 20 weeks and at the latest at V8, confirmed at the Consolidation Visit without loss of clinical response defined as DAS28 (CRP) >3.2. (NCT01219933)
Timeframe: Visits 3 (7 months), 4 (8 months), 5 (9 months), 6 (10 months), 7 (11 months), and 8 (12 months)

Interventionpercentage of participants (Number)
Tocilizumab58.1

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Percentage of Participants With Changes in RA Treatment During the Noninterventional Phase

(NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionpercentage of participants (Number)
Tocilizumab15.2

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Time-Averaged GC Dose Changes During the Interventional Phase

"Area Under the Curve (AUC) of GC dose during the interventional phase was determined using the trapezoidal method and was calculated as:~AUC = sigma(Ti+1 - Ti) x [(Di+1+Di)/2]~With Di=dosage at time Ti~It corresponds to the total GC dose received between Baseline (visit 3) and visit 9 and has been calculated only for the 30 patients achieving visit 9." (NCT01219933)
Timeframe: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionmg (Mean)
Tocilizumab341.8

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CDAI Score During the Interventional Phase

The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-100 mm VAS; higher scores=greater affection due to disease activity. CDAI total score=0-76. CDAI ≤2.8=disease remission, >2.8 to 10=LDA, >10 to 22=moderate disease activity, and >22=high disease activity. V3, CV, and the change from V3 to CV was determined. (NCT01219933)
Timeframe: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionunits on a scale (Mean)
V3 (n=40)CV (n=27)Change from V3 to CV (n=25)
Tocilizumab5.66.51.4

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Clinical Disease Activity Index (CDAI) During the Noninterventional Phase

The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and Physician Global Assessment (PGA) of disease assessed on 0-100 mm Visual analog scale (VAS); higher scores=greater affection due to disease activity. CDAI total score=0-76. CDAI ≤2.8=disease remission, >2.8 to 10=LDA, >10 to 22=moderate disease activity, and >22=high disease activity. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionunits on a scale (Mean)
V1 (n=62)V2 (n=52)Change from V1 to V2 (n=50)
Tocilizumab33.814.6-20.4

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DAS28-CRP During the Interventional Phase

DAS28-CRP was calculated from the SJC and TJC using the 28-joint count and CRP (mg/L). Total score range: 0 to 10, higher score indicated more disease activity. DAS28-CRP) ≤3.2=LDA and >3.2 to 5.1=moderate to high disease activity, and DAS28-CRP <2.6=remission. DAS28-CRP values indicated in the CRF were recalculated by the data manager. The cumulative DAS28 (CRP) value (AUC method) was performed using the calculated DAS28. The recalculated values were used in the statistical analyses. (NCT01219933)
Timeframe: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionunits on a scale (Mean)
V3 (n=42)CV (n=27)Change from V3 to CV (n=27)
Tocilizumab2.22.30.2

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SJC and TJC During the Interventional Phase

TJC and SJC were assessed for 28 joints. An assessment of 28 joints for swelling and tenderness was made. Joints were assessed and classified as swollen (1)/not swollen (0) and tender (1)/not tender (0) by pressure and joint manipulation on physical examination for a total score range of 0-28. Higher scores indicated greater disease activity (tenderness/swelling). V3, CV, and the change from V3 to CV was determined. (NCT01219933)
Timeframe: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionjoints (Mean)
SJC V3 (n=43)SJC CV (n=29)SJC Change from V3 to CV (n=29)TJC V3 (n=43)TJC CV (n=29)TJC Change from V3 to CV (n=29)
Tocilizumab0.90.4-0.30.91.81.0

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Percentage of Participants Positive for Rheumatoid Factor (RF) During the Noninterventional Phase

RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 units per milliliter (U/mL) is considered positive. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionpercentage of participants (Number)
V1 (n=39)Between V1 and V2 (n=21)
Tocilizumab56.452.4

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DAS28-CRP During the Noninterventional Phase

DAS28-CRP was calculated from the swollen joint count (SJC) and tender joint count (TJC) using the 28-joint count and CRP (mg/L). Total score range: 0 to 10, higher score indicated more disease activity. DAS28-CRP ≤3.2=LDA and >3.2 to 5.1=moderate to high disease activity, and DAS28-CRP <2.6=remission. Timepoint was V2, or before V2 for participants withdrawn before V2; DAS28-CRP values indicated in the Case Report Form (CRF) were recalculated by the data manager. The recalculated values were used in the statistical analyses. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionunits on a scale (Mean)
V1 (n=67)V2 (n=66)Change from V1 to V2 (n=65)
Tocilizumab5.42.9-2.5

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DAS28-ESR During the Noninterventional Phase

DAS28-ESR was calculated from the SJC and TJC using the 28 joints count and ESR (millimeters per hour [mm/hr]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-ESR ≤3.2=LDA and >3.2 to 5.1=moderate to high disease activity, and DAS28-ESR <2.6=remission. Timepoint was V2, or before V2 for participants withdrawn before V2; DAS28-ESR values indicated in the CRF were recalculated by the data manager. The recalculated values were used in the statistical analyses. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionunits on a scale (Mean)
V1 (n=62)V2 (n=52)Change from V1 to V2 (n=50)
Tocilizumab5.83.3-2.7

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Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score During the Interventional Phase

FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score). V3, CV, and the change from V3 to CV was determined. (NCT01219933)
Timeframe: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionunits on a scale (Mean)
V3 (n=37)CV (n=26)Change from V3 to CV (n=22)
Tocilizumab37.535.68.8

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Percentage of Participants With LDA or Remission During the Interventional Phase Assessed Using DAS28-CRP

DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joint count, the CRP and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28-CRP ≤3.2 and oral GC intake with MP equivalent dose of ≥1 mg and ≤20 mg/day=LDA; DAS28 <2.6 = remission. (NCT01219933)
Timeframe: Visits 3 (7 months), 4 (8 months), 5 (9 months), 6 (10 months), 7 (11 months), 8 (12 months), 9 (24 weeks after V3) or CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionpercentage of participants (Number)
V3 LDA (n=42)V3 Remission (n=42)V4 LDA (n=41)V4 Remission (n=41)V5 LDA (n=35)V5 Remission (n=35)V6 LDA (n=35)V6 Remission (n=35)V7 LDA (n=33)V7 Remission (n=33)V8 LDA (n=32)V8 Remission (n=32)V9 LDA (n=30)V9 Remission (n=30)CV LDA (n=27)CV Remission (n=27)
Tocilizumab90.573.885.473.288.671.482.962.990.957.687.562.573.356.788.959.3

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VAS-Physician's Global Assessment of Disease Activity (GDA) During the Interventional Phase

Physician's were asked to determine the overall GDA for each participant using a 100-mm VAS, where 0=no disease activity and 100=maximum disease activity. The physician marked the line corresponding to their assessment and the distance from the left edge was measured. V3, CV, and the change from V3 to CV was determined. (NCT01219933)
Timeframe: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionmm (Mean)
V3 (n=40)CV (n=28)Change from V3 to CV (n=26)
Tocilizumab16.616.73.1

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VAS for Pain (VAS-Pain) During the Interventional Phase

Participants were asked to mark the line corresponding to the intensity of their pain on a 100-mm VAS, where 0=no pain and 100=worst possible pain. The distance from the left edge was measured. Change = V3 mean minus CV mean. (NCT01219933)
Timeframe: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionmm (Mean)
V3 (n=43)CV (n=28)Change from V3 to CV (n=28)
Tocilizumab19.924.96.9

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Percentage of Participants Positive for Anti-cyclic Citrullinated Peptide (Anti-CCP) Antibody During the Noninterventional Phase

Anti-CCP antibodies are important markers of bone erosion in RA. Anti-CCP antibodies were classified as positive if >7 U/mL. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionpercentage of participants (Number)
V1 (n=20)Between V1 and V2 (n=6)
Tocilizumab75.083.3

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Type of GC Taken at the End of the Noninterventional Phase

During the noninterventional phase of the study participants received GC as prescribed by the physician. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionpercentage of participants (Number)
MPPrednisolonePrednisone
Tocilizumab70.028.02.0

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HAQ-DI During the Interventional Phase

HAQ-DI is a self-reported, valid assessment of functional disability in RA. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ-DI score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. V3, CV, and the change from V3 to CV was determined. (NCT01219933)
Timeframe: Visit 3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionunits on a scale (Mean)
V3 (n=41)CV (n=28)Change from V3 to CV (n=26)
Tocilizumab1.00.80.0

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Health Assessment Questionnaire Disability Index (HAQ-DI) During the Noninterventional Phase

HAQ-DI is a self-reported, valid assessment of functional disability in RA. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ-DI score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. Timepoint was V2, or before V2 for participants withdrawn before V2. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionunits on a scale (Mean)
V1 (n=66)V2 (n=61)Change from V1 to V2 (n=60)
Tocilizumab1.71.2-0.5

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Median GC Dose Taken During the Noninterventional Phase

During the noninterventional phase of the study participants received GC as prescribed by the physician. Doses of all GC administered are expressed as MP equivalents. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionmg (Median)
Start dose V1 (n=68)Start dose (V1) for Interventional phase (n=50)Stop dose (V2; n=50)Change from start to stop (n=50)Cumulative dose from V1 to V2 (n=45)
Tocilizumab6640320

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Number of Erosions During the NonInterventional Phase

In RA, the presence, number, and size of bone erosions and the number of joints with erosions on CRs are hallmarks for diagnosis, staging and prediction of damage progression and are used for treatment monitoring in randomized controlled studies. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionerosions (Mean)
V1 (n=11)Between V1 and V2 (n=6)
Tocilizumab5.13.2

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Short-Form 36 (SF-36) Mental Component Score (MCS) and Physical Component Score (PCS) During the Interventional Phase

"36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (PCS and MCS). Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 how would you rate your health in general now? (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores reflect higher quality of life. V3, CV, and the change from V3 to CV was determined." (NCT01219933)
Timeframe: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionunits on a scale (Mean)
MCS V3 (n=37)MCS CV (n=26)MCS: Change from V3 to CV (n=22)PCS V3 (n=36)PCS CV (n=26)PCS: Change from V3 to CV (n=22)
Tocilizumab47.046.2-4.442.541.8-2.1

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Percentage of Participants With Erosions During the NonInterventional Phase

In RA, the presence, number and size of bone erosions and the number of joints with erosions on conventional radiographs (CRs) are hallmarks for diagnosis, staging and prediction of damage progression and are used for treatment monitoring in randomized controlled studies. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionpercentage of participants (Number)
V1 (n=57)Between V1 and V2 (n=36)
Tocilizumab47.441.7

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Percentage of Participants With LDA or Remission During the Interventional Phase Assessed Using CDAI

The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-100 mm VAS; higher scores=greater affection due to disease activity. CDAI total score=0-76. CDAI ≤2.8=disease remission and >2.8 to 10=LDA. (NCT01219933)
Timeframe: Visits 3 (7 months), 4 (8 months), 5 (9 months), 6 (10 months), 7 (11 months), 8 (12 months), and 9 (24 weeks after V3) or CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionpercentage of participants (Number)
V3 LDA (n=40)V3 Remission (n=40)V4 LDA (n=41)V4 Remission (n=41)V5 LDA (n=38)V5 Remission (n=38)V6 LDA (n=35)V6 Remission (n=35)V7 LDA (n=33)V7 Remission (n=33)V8 LDA (n=31)V8 Remission (n=31)V9 LDA (n=29)V9 Remission (n=29)CV LDA (n=27)CV Remission (n=27)
Tocilizumab85.027.582.939.081.647.471.437.175.833.380.638.769.031.077.833.3

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SF-36 Subscale Scores During the Interventional Phase

"SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (PCS and MCS). Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 how would you rate your health in general now? (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores reflect higher quality of life. V3, CV, and the change from V3 to CV was determined." (NCT01219933)
Timeframe: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionunits on a scale (Mean)
Physical functioning V3 (n=36)Physical functioning CV (n=26)Change in physical functioning V3 to CV (n=22)Physical sub-score V3 (n=37)Physical sub-score CV (n=26)Change in physical sub-score V3 to CV (n=22)Bodily pain V3 (n=37)Bodily pain CV (n=26)Change in bodily pain V3 to CV (n=22)General health V3 (n=37)General health CV (n=26)Change in general health V3 to CV (n=22)Vitality V3 (n=37)Vitality CV (n=26)Change in vitality V3 to CV (n=22)Social functioning V3 (n=37)Social functioning CV (n=26)Change in social functioning V3 to CV (n=22)Emotional sub-score V3 (n=37)Emotional sub-score CV (n=26)Change in emotional sub-score V3 to CV (n=22)Mental health V3 (n=37)Mental health CV (n=26)Change in Mental health V3 to CV (n=22)
Tocilizumab41.5241.92-1.8040.6139.85-2.7945.8844.65-3.2143.1140.82-3.7850.5148.91-4.3745.4245.58-2.7340.5940.37-2.4547.1445.94-5.47

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Plasma Decay Half-life (t1/2)

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. (NCT01267201)
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose

Interventionhr (Mean)
Methylprednisolone 32 mg Tablet2.43
Methylprednisolone 32 mg Micronized API2.42
Methylprednisolone 32 mg Sieve Cut API2.45

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Time to Reach Maximum Observed Plasma Concentration (Tmax)

(NCT01267201)
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose

Interventionhr (Median)
Methylprednisolone 32 mg Tablet2.00
Methylprednisolone 32 mg Micronized API1.00
Methylprednisolone 32 mg Sieve Cut API2.00

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Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]

AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). (NCT01267201)
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hours (hrs) post-dose

Interventionng*hr/mL (Geometric Mean)
Methylprednisolone 32 mg Tablet1286.00
Methylprednisolone 32 mg Micronized API1204.00
Methylprednisolone 32 mg Sieve Cut API1180.00

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Maximum Observed Plasma Concentration (Cmax)

(NCT01267201)
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose

Interventionng/mL (Geometric Mean)
Methylprednisolone 32 mg Tablet289.00
Methylprednisolone 32 mg Micronized API279.10
Methylprednisolone 32 mg Sieve Cut API246.20

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Progression to Clinically Significant Lower Respiratory Tract Symptoms

Progression to clinically significant lower respiratory tract symptoms defined by: (1) having symptoms that were more than mild after 3 albuterol administrations over 1 hour, or (2) requiring albuterol administrations more often than once every 4 hours, or (3) requiring more than 6 albuterol treatments over a 24-hour period, or (4) having moderate to severe cough or wheeze for 5 or more days since study medication was initiated. (NCT01272635)
Timeframe: 14 days after initiation of APRIL therapy

Interventionparticipants (Number)
Azythromycin35
Placebo57

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OCELOT: Pediatric Respiratory Assessment Measure

The Pediatric Respiratory Assessment Measure (PRAM) is a composite outcome with scores ranging from 0-12 with higher numbers representing worse symptoms. The score is calculated as the sum total of the follow five elements: (1) scalene retractions, (2) suprasternal retractions, (3) wheezing, (4) air entry, (5) oxygen saturation. A complete description can be found in: Ducharme FM, Chalut D, Plotnick L, et al. The Pediatric Respiratory Assessment Measure: a valid clinical score for assessing acute asthma severity from toddlers to teenagers. J Pediatr 2008;152:476-80. (NCT01272635)
Timeframe: 36-72 hours after initiation of OCELOT therapy

InterventionPRAM score (Mean)
Prednisone0.82
Placebo1.00

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Urgent Care Visits, ED Visits and Hospitalizations

Number of participants who had urgent care visits, ED visits, and/or hospitalizations for respiratory symptoms. (NCT01272635)
Timeframe: 14 days after initiation of therapy

Interventionparticipants (Number)
Azythromycin20
Placebo38

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60-day Mortality

The primary outcome is all-cause mortality at 60 days, defined by whether the patient has died by the end of study day 60. (NCT01283009)
Timeframe: 60-day

InterventionParticipants (Count of Participants)
Died on or prior to study day 6072325123Died on or prior to study day 6072325124On Mechanical Ventilation at Study Entry72325123On Mechanical Ventilation at Study Entry72325124Not on Mechanical Ventilation72325123Not on Mechanical Ventilation72325124
YesNoUnknown
Arm 1: Inactive Substance50
Arm 2: Methylprednisolone47
Arm 1: Inactive Substance227
Arm 2: Methylprednisolone239
Arm 1: Inactive Substance10
Arm 2: Methylprednisolone11
Arm 1: Inactive Substance24
Arm 2: Methylprednisolone22
Arm 1: Inactive Substance70
Arm 2: Methylprednisolone72
Arm 1: Inactive Substance2
Arm 2: Methylprednisolone3
Arm 1: Inactive Substance26
Arm 2: Methylprednisolone25
Arm 1: Inactive Substance157
Arm 2: Methylprednisolone167
Arm 1: Inactive Substance8
Arm 2: Methylprednisolone8

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Overall Survival

Time from date of treatment start until date of death due to any cause or last Follow-up. Survival will be measured by the estimated median survival computed by Kaplan-Meier (K-M) analysis, which is the time point at which the cumulative survival drops below 50%, if present. If not present then the median Overall Survival is not reached and not available (NA) as there are an insufficient number of participants with events. In either case ranges are provided for observed survival intervals used in the K-M analysis. (NCT01319981)
Timeframe: Up to 7 years, 8 months

InterventionMonths (Median)
Hyper-CMAD + RituximabNA
Hyper-CMADNA

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Number of Patients With Complete Remission at One Year

The complete remission (CR) is the total number of patients who are in CR at one year divided by the total number of patients who received at least one dose of HCVAD with liposomal vincristine. CR was defined as the presence of 1x10^9/L neutrophils, >100x10^9/L platelets in the perpherial blood, and no extramedullary disease. (NCT01319981)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Hyper-CMAD + Rituximab12
Hyper-CMAD13

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Complete Response Duration

The complete remission (CR) is the total number of patients who are in CR at one year divided by the total number of patients who received at least one dose of HCVAD with liposomal vincristine. CR was defined as the presence of 1x10^9/L neutrophils, >100x10^9/L platelets in the perpherial blood, and no extramedullary disease. Response date to loss of response or last follow up. Remission duration will be measured by the estimated median remission duration computed by Kaplan-Meier (K-M) analysis, which is the time point at which the cumulative remission duration drops below 50%, if present. If not present then median remission duration is not reached and not available (NA) as there are an insufficient number of participants with events. In either case ranges are provided for observed survival intervals used in the K-M analysis.. (NCT01319981)
Timeframe: Up to 7 years, 8 months

InterventionMonths (Median)
Hyper-CMAD + RituximabNA
Hyper-CMADNA

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Change From Baseline in DAS28-CRP at 12 Weeks

"The primary efficacy endpoint was the mean change in Disease Activity Score 28 using C-reactive protein (DAS28-CRP) from baseline to Week 12.~The DAS28-CRP is a composite measure of inflammation in Rheumatoid Arthritis and incorporates a tender and swollen joint count, CRP and Patient Global Assessment of Disease Activity expressed in a Gaussian distribution of variables ranging from 0 to 10. A DAS28-CRP score of <3.2 suggests a low level of disease activity, while a score of >5.1 suggests a high level of disease activity. Using the DAS-CRP as a continuous scale allows investigators (and clinicians) to measure a clinically meaningful endpoint following institution of a therapeutic intervention. In RA, clinical remission would therefore be graded as a DAS28 score of ≤3.2 with disease flare accompanying scores of ≥5.1; well-controlled disease is best characterized as fitting in between these two scores." (NCT01369745)
Timeframe: baseline to week 12

Interventionunits on a scale (Mean)
Prednisolone-1.147
Dipyridamole-0.813
Prednisone-1.237
Z102-0.907
Placebo-0.538

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Change From Baseline in Serum Endocrine Biomarkers (Progesterone and Testosterone) at End of Treatment

Change from baseline in serum endocrine biomarkers (Progesterone and Testosterone) was summarized by treatment at end of treatment. (NCT01381874)
Timeframe: Baseline and End of treatment (approximately 2 years)

,,
InterventionNanomoles Per Liter (nmol/L) (Mean)
ProgesteroneTestosterone
Abiraterone Acetate + Exemestane + Prednisone12.34-0.48
Abiraterone Acetate + Prednisone8.98-0.51
Exemestane-4.80-0.09

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Overall Response Rate (ORR)

Overall response rate was defined as the percentage of participants with measurable disease achieving a best overall response of either complete response (CR) or partial response (PR) based on RECIST. CR: disappearance of all target lesions and non-target lesions. PR: at least a 30 percent (%) decrease in the sum of longest diameter (LD) of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. (NCT01381874)
Timeframe: Approximately 2 years

InterventionPercentage of participants (Number)
Exemestane6.3
Abiraterone Acetate + Prednisone5.8
Abiraterone Acetate + Exemestane + Prednisone12.1

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Change From Baseline in Serum Endocrine Biomarkers (Estradiol and Estrone) at End of Treatment

Change from baseline in serum endocrine biomarkers (estradiol and estrone) was summarized by treatment at end of treatment. (NCT01381874)
Timeframe: Baseline and End of treatment (approximately 2 years)

,,
InterventionPicomoles Per Liter (Pmol/L) (Mean)
EstradiolEstrone
Abiraterone Acetate + Exemestane + Prednisone-1.04-30.60
Abiraterone Acetate + Prednisone-3.35-28.09
Exemestane1.53-34.20

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Duration of Response

Duration of objective response was measured from the first time that the CR or PR was achieved to the first observation of disease progression (either radiographic or clinical) based on the RECIST criteria. (NCT01381874)
Timeframe: Approximately 2 years

Interventionmonths (Median)
Exemestane6.47
Abiraterone Acetate + Prednisone4.86
Abiraterone Acetate + Exemestane + Prednisone6.93

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Clinical Benefit Rate

Clinical benefit rate was defined as the percentage of participants with measurable disease achieving a best overall response of a CR, PR, or stable disease (SD) for at least 6 months based on RECIST. Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study and persistence of one or more non-target lesion(s) and/or maintenance of tumour marker level above the normal limits. (NCT01381874)
Timeframe: Approximately 2 years

InterventionPercentage of participants (Number)
Exemestane12.7
Abiraterone Acetate + Prednisone9.6
Abiraterone Acetate + Exemestane + Prednisone22.7

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Progression-Free Survival (PFS)

Progression-free survival was defined as the time from randomization to first occurrence of disease progression (either radiographic or clinical), or death from any cause. PFS was determined using radiographic progression defined by Response Evaluation Criteria in Solid Tumors (RECIST) on measurable lesions captured by computed tomography (CT) or magnetic resonance imaging (MRI). Clinical disease progression was considered only when disease progression could not be confirmed by CT or MRI, such as when the disease site is skin, bone marrow, or central nervous system. (NCT01381874)
Timeframe: Approximately 2 years

InterventionMonths (Median)
Exemestane3.68
Abiraterone Acetate + Prednisone3.65
Abiraterone Acetate + Exemestane + Prednisone4.47

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Overall Survival (OS)

OS was calculated as the time from randomization to death from any cause. (NCT01381874)
Timeframe: Approximately 3 years

InterventionMonths (Median)
ExemestaneNA
Abiraterone Acetate + Prednisone26.41
Abiraterone Acetate + Exemestane + PrednisoneNA

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Number of Eyes With Intraocular Pressure (IOP) Elevation

Absolute IOP greater than or equal to 24 mm Hg or a relative increase of 10 mm Hg over the baseline preoperative reading. (NCT01448213)
Timeframe: one day, two days, one week, one month, 3 months, 6 months and 12 months after DMEK

Interventioneyes (Number)
Fluorometholone 0.1% Solution9
Prednisolone Acetate 1% Solution32

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Number of Eyes With Immunologic Graft Rejection Episodes

(NCT01448213)
Timeframe: Within 1 year

Interventioneyes (Number)
Fluorometholone 0.1% Solution2
Prednisolone Acetate 1% Solution0

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Number of Participants Completing Part A Treatment

Participants counted as completing Part A with either 2 or 4 cycles of treatment per protocol. (NCT01465334)
Timeframe: Evaluated up to 4 cycles/16 weeks.

Interventionparticipants (Number)
Treatment Naive12
Relapsed/Refractory15

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Number of Participants Achieving Induction Complete Response (CR)

CR over induction treatment was based on International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008). There are numerous diagnostic tests used for response evaluation including potentially CBC and differential count, marrow aspirate and biopsy, ultrasound of the abdomen, CT scans (chest, pelvis, abdomen) and physical examination. CR is absence of significant lymphadenopathy (nodes<1.5 centimeters in long axis diameter), hepatomegaly, splenomegaly as well as blood lymphocytes<4000/microliter, normocellular for age marrow with <30% lymphocytes, no B-lymphoid nodules and platelet>100,000/micro liter, hemoglobin>11 grams/deciliter, neutrophils>1500/microliter. (NCT01465334)
Timeframe: Disease was evaluated after weeks 8 and 16 of Part A and at 12, 18 and 24 weeks during part B.

Interventionparticipants (Number)
Treatment Naive0
Relapsed/Refractory0

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Induction Overall Response Rate (ORR)

Induction ORR is the percentage of participants achieving a minimum of partial response (PR) over induction treatment based on International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008). There are numerous diagnostic tests used for response evaluation including potentially CBC and differential count, marrow aspirate and biopsy, ultrasound of the abdomen, CT scans (chest, pelvis, abdomen) and physical examination. PR is a 50% or greater decrease of measured size of lymphadenopathy, hepatomegaly, splenomegaly as well as blood lymphocytes (over baseline), marrow infiltrate or B-lymphoid nodules and a 50% or greater increase from baseline in platelet count (or level >100,000/micro liter), hemoglobin (or level >11 grams/deciliter), neutrophils (or level >1500/microliter). (NCT01465334)
Timeframe: Disease was evaluated after weeks 8 and 16 of Part A and at 12, 18 and 24 weeks during part B.

Interventionpercentage of participants (Number)
Treatment Naive73
Relapsed/Refractory60

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3-Year Progression-Free Survival (PFS) Probability

3-year PFS is the probability of participants remaining alive and progression-free at 3 years from study entry estimated using Kaplan-Meier methods. Disease progression (PD) per International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008) is: the appearance of any new lesion (enlarged lymph node minimum >1.5 centimeters); an increase by 50% in greatest determined diameter of any previous site; an increase in the previously noted enlargement of the liver or spleen by 50% or more or the de novo appearance of hepatomegaly, splenomegaly; a 50% increase of blood lymphocytes (over baseline with level at least 5,000/microliter); occurrence of cytopenia secondary to CLL at least 3 months post treatment including a 50% or greater decrease from baseline in platelet count (or level <100,000/microliter) or a hemoglobin decrease of >2 grams/deciliter (or level <10 grams/deciliter); and transformation to a more aggressive histology. (NCT01465334)
Timeframe: Disease was evaluated on treatment after weeks 8 and 16 of Part A, at 12, 18 and 24 weeks during part B and every 6 months on Part C as well as off-treatment every 3 months up to 5 years.

Interventionpercentage probability (Number)
Treatment Naive53
Relapsed/Refractory25

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3-year Overall Survival (OS) Probability

3-year OS is the probability of participants remaining alive at 3 years from study entry estimated using Kaplan-Meier methods. (NCT01465334)
Timeframe: Median survival follow-up was 45 months (range 31-58 months) in this study cohort.

Interventionpercentage probability (Number)
Treatment Naive66
Relapsed/Refractory53

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Number of Participants With Overall CR

CR overall (induction and maintenance treatment) was based on International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008). There are numerous diagnostic tests used for response evaluation including potentially CBC and differential count, marrow aspirate and biopsy, ultrasound of the abdomen, CT scans (chest, pelvis, abdomen) and physical examination. CR is absence of significant lymphadenopathy (nodes<1.5 centimeters in long axis diameter), hepatomegaly, splenomegaly as well as blood lymphocytes<4000/microliter, normocellular for age marrow with <30% lymphocytes, no B-lymphoid nodules and platelet>100,000/micro liter, hemoglobin>11 grams/deciliter, neutrophils>1500/microliter. (NCT01465334)
Timeframe: Disease was evaluated after weeks 8 and 16 of Part A, at 12, 18 and 24 weeks during part B and every 6 months on Part C.

Interventionparticipants (Number)
Treatment Naive2
Relapsed/Refractory0

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Number of Participants Completing Only 2 Cycles of Part A Treatment

Participants counted if only completed 2 cycles of Part A treatment per protocol. (NCT01465334)
Timeframe: Evaluated after 2 cycles/8 weeks of Part A therapy.

Interventionparticipants (Number)
Treatment Naive0
Relapsed/Refractory0

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Transplant Rate

Percentage of participants eligible for allogeneic hematopoietic stem cell transplantation (alloHSCT) that are able and willing to proceed to alloHSCT. (NCT01465334)
Timeframe: Evaluated up to 36 cycles (approximately 2.75 years) of treatment (Parts A, B and C)

Interventionpercentage of participants (Number)
Treatment Naive43
Relapsed/Refractory43

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Overall Objective Response Rate (ORR)

Overall ORR is the percentage of participants achieving a minimum of partial response (PR) over induction and maintenance treatment based on International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008). There are numerous diagnostic tests used for response evaluation including potentially CBC and differential count, marrow aspirate and biopsy, ultrasound of the abdomen, CT scans (chest, pelvis, abdomen) and physical examination. PR is a 50% or greater decrease of measured size of lymphadenopathy, hepatomegaly, splenomegaly as well as blood lymphocytes (over baseline), marrow infiltrate or B-lymphoid nodules and a 50% or greater increase from baseline in platelet count (or level >100,000/micro liter), hemoglobin (or level >11 grams/deciliter), neutrophils (or level >1500/microliter). (NCT01465334)
Timeframe: Disease was evaluated after weeks 8 and 16 of Part A, at 12, 18 and 24 weeks during part B and every 6 months on Part C.

Interventionpercentage of participants (Number)
Treatment Naive80
Relapsed/Refractory67

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Overall MRD Negative Rate

Overall MRD negative rate is the percentage of participants classified as MRD negative by four color flow cytometry. The assay has a sensitivity of 1 in 10,000 leukocytes. (NCT01465334)
Timeframe: MRD was assessed after weeks 8 and 16 of Part A, at 12, 18 and 24 weeks during part B and every 6 months on Part C.

Interventionpercentage of participants (Number)
Treatment Naive80
Relapsed/Refractory53

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Anterior Chamber Inflammation

"Anterior Chamber Inflammation (for subjects that could only be examined with a pen light and a 20D [g20 Diopter] magnifying lens): 0 = None Clear anterior chamber with no visible clouding (Tyndall effect and cells combined). Red reflex normal~= Mild Mild anterior chamber clouding. Clear iris pattern on visualization. Red reflex normal~= Moderate Moderate anterior chamber clouding~= Severe Severe anterior chamber clouding. Iris pattern not clearly visualized. Red reflex diminished~= Very severe Severe anterior chamber clouding with a white and/or milky appearance of the anterior chamber. Red reflex absent or severely diminished" (NCT01475643)
Timeframe: Postoperative Day 29

Interventiongrade of anterior chamber cells (Mean)
Loteprednol Etabonate.913
Prednisolones Acetate.783

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Anterior Chamber Cells & Flare

"Anterior Chamber Flare (for those subjects that could be examined with a slit lamp):~Assessed scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0 = None No Tyndall effect~= Mild Tyndall effect barely discernible~= Moderate Tyndall effect in anterior chamber is moderately intense. Iris pattern is seen clearly~= Severe Tyndall effect in anterior chamber is severely intense. Iris pattern cannot be seen clearly~= Very severe Tyndall effect is very severely intense. The aqueous has a white and milky appearance" (NCT01475643)
Timeframe: Over all visits 42 days

InterventionGrade of anterior chamber flare (Mean)
Loteprednol Etabonate.192
Prednisolones Acetate.341

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Number of Participants With Overall Survival (OS)

Overall survival will be summarized with the Kaplan-Meier curve. (NCT01496976)
Timeframe: 36 Months

Interventionparticipants (Number)
Immunotherapy24

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Rate of Progression/Relapse Free Survival (PFS)

Progression-free survival (PFS), defined as the time from study entry to disease progression, relapse or death due to any cause, whichever is earlier. (NCT01496976)
Timeframe: Up to 56 months

Interventionmonths (Median)
Immunotherapy54.4

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Number of Participants With Complete Response (CR)

Number of participants with complete response, the disappearance of all signs of cancer in response to treatment. (NCT01496976)
Timeframe: 3 Months

InterventionParticipants (Count of Participants)
Immunotherapy1

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Number of Participants With Partial Response (PR)

The primary endpoint for this trial is the combined complete and partial response rate to the protocol therapy at 3 months, which is also the end of Cycle 3. The objective response (CR+PR) rate will be summarized using both a point estimate and its exact confidence interval based on the binomial distribution. (NCT01496976)
Timeframe: 3 Months

Interventionparticipants (Number)
Immunotherapy33

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Objective Response Rate (ORR)

ORR at 3 months. Assessment for response will be made following the National Cancer Institute Working Group (NCIWG) 2008 Chronic Lymphocytic Leukemia (CLL) criteria for response. Objective response = Complete Response (disappearance of all target lesions) + Partial Response (>=30% decrease in the sum of the longest diameter of target lesions) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) (NCT01497496)
Timeframe: 3 Months

Interventionpercentage of participants (Number)
Immunotherapy48.3

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Episcleral Redness Change From Baseline to Day 6

Episcleral redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC.0 was best (least redness), and 4 was worst (most redness). (NCT01534195)
Timeframe: 7 minutes post-CAC

Interventionscore on a scale (Mean)
Prednisolone-1.0
Placebo0.45

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Ciliary Redness Change From Baseline to Day 6

Ciliary redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC. 0 was best (least redness), and 4 was worst (most redness). (NCT01534195)
Timeframe: 7 minutes post-CAC

Interventionscore on a scale (Mean)
Prednisolone-0.94
Placebo0.30

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Ocular Itching Change From Baseline to Day 11

Ocular itching, as assessed by the participant, was measured on a 4-point scale 5 minutes after the conjunctival allergen challenge (CAC). 0 was best (no itching), and 4 was worst (worst itching). (NCT01534195)
Timeframe: 5 minutes post-CAC

Interventionunits on a scale (Mean)
Prednisolone-1.1
Placebo-0.45

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Conjunctival Redness Change From Baseline to Day 11

Conjunctival Redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC. 0 was best (no redness), and 4 was worst (most redness) (NCT01534195)
Timeframe: 7 Minutes post-CAC

Interventionscore on a scale (Mean)
Prednisolone-0.69
Placebo0.40

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Orthostatic Hypotension

(NCT01559675)
Timeframe: Postoperative Day 1

Interventionparticipants (Number)
High Dose Steroid2
Low Dose Steroid2

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Neurodevelopmental Outcome

Bayley Scales of Infant and Toddler Development version 3 at 1 year. Cognitive, language, and motor composite scores will be used. The general population has a mean of 100 with a standard deviation of 15 for each composite score. Higher scores are better. The minimum composite score is 46 and maximum 154. (NCT01579513)
Timeframe: 1 year

,
Interventionscore on a scale (Mean)
Cognitive DomainLanguage DomainMotor Domain
Intraoperative Methylprednisone10510190
Placebo10410091

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Hospital Stay

Total duration of hospital stay following cardiac surgery (NCT01579513)
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks

InterventionDays (Mean)
Intraoperative Methylprednisone20
Placebo22

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Intensive Care Unit Stay

Amount of time in the intensive care unit following cardiac surgery (NCT01579513)
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks

InterventionDays (Mean)
Intraoperative Methylprednisone11
Placebo11

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Duration of Mechanical Ventilation Post Cardiac Surgery.

Amount of time on mechanical ventilation following cardiac surgery (NCT01579513)
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks

InterventionDays (Median)
Intraoperative Methylprednisone4
Placebo5

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Number of Participants With a Clinically Derived Composite Morbidity-mortality Outcome

The composite morbidity-mortality outcome will be met if any of the following occur after surgery but before hospital discharge: death, cardiac arrest, extracorporeal membrane oxygenation, renal insufficiency (creatinine more than two times normal), hepatic insufficiency (aspartate aminotransferase or alanine aminotransferase more than two times normal), or rising lactic acidosis (>5mmol/L). This outcome was choosen because death rarely occurs in this population. We have found this endpoint to be highly associated with other important clinical outcomes in this population. (NCT01579513)
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks

InterventionParticipants (Count of Participants)
Intraoperative Methylprednisone27
Placebo40

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Percentage of Patients With Suppression of Hypothalamus-pituitary-adrenal Axis

"Evaluation of blood cortisol and ACTH, free urinary cortisol, urinary levels of methylprednisolone or triamcinolone (depending on the administered drug) by RIA immunoassay and tandem mass assays~Persistent suppression of the HPA axis at the end of the follow up is based on the evidence of ACTH, plasmatic and urinary cortisol levels under reference values" (NCT01652495)
Timeframe: 45 days after treatment

Intervention% of patients with HPA suppression (Number)
Methylprednisolone Acetate Group0
Triamcinolone Acetonide Group15

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Reduction of Pain Severity Expressed as Percentage Change in VAS Score

"VAS score~VAS score is a 10 -cm graduated scale with scores ranging from 0 (no pain) to 10 (unbearable pain) self- reported by patients~Reference: Langley GB and Sheppeard H. The visual analogue scale: its use in pain measurement. Rheumatol Int 1985;5(4):145-148." (NCT01652495)
Timeframe: 180 days after treatment

Interventionpercentage of pain reduction (Mean)
Methylprednisolone Acetate Group82
Triamcinolone Acetonide Group96

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Functional Improvement Measured According to Percentage Change in Constant Score

"Patients will be evaluated clinically by Constant Score~Constant score: range 0 (total shoulder impairment) to 100 (non impaired shoulder). The score is obtained from two subjective (pain and relation between pain and daily-life activities) - and two objective physician-assessed (strength and range of motion) measurements~Reference: Constant CR and Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4." (NCT01652495)
Timeframe: 180 days after treatment

Interventionpercentage of improvement Constant score (Mean)
Methylprednisolone Acetate Group99
Triamcinolone Acetonide Group95

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Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 8

Participants who preferred rituximab SC over rituximab IV, along with the corresponding 95% confidence interval (CI), were estimated using the patient preference questionnaire (PPQ) after completing Cycle 8. (NCT01724021)
Timeframe: Cycle 8 (Up to 32 weeks)

Interventionpercentage of participants (Number)
Arm A77.1
Arm B84.2

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Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 6

Participants who preferred rituximab SC over rituximab IV, along with the corresponding 95% confidence interval (CI), were estimated using the patient preference questionnaire (PPQ) after completing cycle 6. (NCT01724021)
Timeframe: Cycle 6 (Up to 24 weeks)

Interventionpercentage of participants (Number)
Arm A79.1
Arm B80.6

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Event-free Survival (EFS)

EFS was defined as the time from randomization to first occurrence of progression or relapse according to IWG response criteria. IWG criteria is defined using the following response categories: CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy; partial response (PR): At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses; stable disease (SD): participants fails to attain the criteria needed for a CR or PR, but does not fulfill those for progressive disease (PD); PD: Lymph nodes considered abnormal if the long axis is more than 1.5 centimeter (cm) regardless of the short axis. Lymph node has a long axis of 1.1 to 1.5 cm, it is considered abnormal if its short axis is more than 1.0. Lymph nodes less than or equal to (<=) 1.0 × <= 1.0 cm would not be considered as abnormal for PD. (NCT01724021)
Timeframe: From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)

Interventionmonths (Median)
Arm ANA
Arm BNA

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Percentage of Participants With Anti-Rituximab Antibodies Over Time

(NCT01724021)
Timeframe: Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)

,
Interventionpercentage of participants (Number)
Cycle 1Cycle 2Cycle 3Cycle 4Interim stagingCycle 5Cycle 6Cycle 7Cycle 8Final stagingFollow-up, 6 monthsFollow-up, 12 monthsEnd of study/early treatment termination
Arm A2.02.10.300000001.82.10.6
Arm B3.02.20.90.300000000.60.6

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Number of Participants With Treatment Emergent Adverse Events (AEs)

An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. (NCT01724021)
Timeframe: Randomization of first participant to clinical cutoff date (Up to 4 years)

Interventionparticipants (Number)
Arm A352
Arm B347

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Overall Survival (OS)

OS was defined as the time from randomization to death from any cause. (NCT01724021)
Timeframe: From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)

Interventionmonths (Median)
Arm ANA
Arm BNA

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Complete Response (CR) Rate

CR rate was assessed according to the International Working Group (IWG) Response Criteria (CHESON ET AL. 1999) and included CR and CR unconfirmed (CRu). CR was defined as complete disappearance of all clinical and radiographic evidence of disease and disease-related symptoms, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. CRu was defined as disappearance of clinical and radiographic evidence of disease and absence of splenomegaly, with regression of lymph nodes by > 75 % but still >1.5 cm in size, and indeterminate bone marrow assessment. Tumor assessments were based on computed tomography (CT) scans with contrast of the neck, chest, and abdomen (if detectable by these techniques) or other diagnostic means, if applicable. Other methods (e.g., MRI) were acceptable for participants in whom contrast CT scans were contraindicated. Due to the limited availability of FDG-PET scanners, an FDG-PET scan was not mandated in the study. (NCT01724021)
Timeframe: 28 days (± 3 days) after Day 1 of the last dose of induction treatment

Interventionpercentage of participants (Number)
Arm A49.2
Arm B52.7

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Time Required for Rituximab Administration (Subcutaneous [SC] or Intravenous [IV])

Administration time was defined as the time from start to end of the SC injection or from start to end of the IV infusion (NCT01724021)
Timeframe: Cycle 1-4, Cycle 5-8 for both SC and IV (Up to 32 weeks)

Interventionminutes (Median)
Rituximab Intravenous (IV)840
Rituximab Subcutaneous (SC)22

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Cancer Therapy Satisfaction Questionnaire (CTSQ) Score

CTSQ is a validated 16-item questionnaire that measures three domains related to participants' satisfaction with cancer therapy. These include expectations of therapy, feelings about side effects, and satisfaction with therapy. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants. (NCT01724021)
Timeframe: During Cycle 4, 8 of treatment (Up to 32 weeks)

,
Interventionunits on a scale (Mean)
Expectations of therapy domainFeelings about side effects domainSatisfaction with therapy domain
Rituximab Intravenous (IV)80.8860.6384.59
Rituximab Subcutaneous (SC)82.0761.6485.42

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Percentage of Participants With Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies Over Time

(NCT01724021)
Timeframe: Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)

,
Interventionpercentage of participants (Number)
Cycle 1Cycle 2Cycle 3Cycle 4Interim stagingCycle 5Cycle 6Cycle 7Cycle 8Final stagingFollow-up, 6 monthsFollow-up, 12 monthsEnd of study/early treatment termination
Arm A11.47.07.17.09.012.516.023.813.310.06.57.73.5
Arm B15.618.223.514.79.710.211.610.911.012.613.48.76.3

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Rituximab Administration Satisfaction Questionnaire (RASQ) Score

The RASQ is a 20-item questionnaire that measures five domains related to the impact of treatment administration. These include physical impact, psychological impact, impact on activities of daily living (ADLs), convenience, and satisfaction. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants. (NCT01724021)
Timeframe: During Cycle 4, 8 of treatment (Up to 32 weeks)

,
Interventionunits on a scale (Mean)
Physical impact domainPsychological Impact domainImpact on activitiesf daily livingConvenience domainSatisfaction domain
Rituximab Intravenous (IV)82.1477.7359.4959.0574.88
Rituximab Subcutaneous (SC)82.0884.0081.8681.0587.26

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Summary of Observed Serum Rituximab Concentration

(NCT01724021)
Timeframe: Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)

,
Interventionmicrogram per milliter (Mean)
Cycle 1Cycle 2Cycle 3Cycle 4Interim stagingCycle 5Cycle 6Cycle 7Cycle 8Final stagingFollow-up, 6 monthsFollow-up, 12 monthsEnd of study/early treatment termination
Arm A3355.925053.162977.087956.6117273.6108030.9100927.795614.0104873.086806.67802.92380.19302.0
Arm B970.124541.146093.959485.577665.370387.398679.7117172.0137048.1120995.78042.91685.39553.9

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Disease-free Survival (DFS)

DFS was defined as the period from the data of the initial CR/CRu until the date of relapse or death from any cause, whichever occurred first. (NCT01724021)
Timeframe: From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)

Interventionmonths (Median)
Arm ANA
Arm BNA

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Progression-free Survival (PFS)

PFS was defined as the time from randomization to the first occurrence of progression or relapse, according to the IWG response criteria. IWG criteria is defined criteria using the following response categories: CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy; PR: At least a 50% decrease in SPD of up to six of the largest dominant nodes or nodal masses; SD: participants fails to attain the criteria needed for a CR or PR, but does not fulfill those for PD; PD: Lymph nodes considered abnormal if the long axis is more than 1.5 cm regardless of the short axis. Lymph node has a long axis of 1.1 to 1.5 cm, it is considered abnormal if its short axis is more than 1.0. Lymph nodes <= 1.0 × <= 1.0 cm would not be considered as abnormal for PD. (NCT01724021)
Timeframe: From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)

Interventionmonths (Median)
Arm ANA
Arm BNA

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Ocular Redness Change From Baseline to Day 6

Ocular redness was measured by the investigator on a 4-point scale 7 minutes post-CAC. 0 = best (no redness), 4 = worst (most redness). (NCT01730872)
Timeframe: 7 minutes post-CAC

Interventionscore on a scale (Mean)
Prednisolone-1.1
Placebo0.31

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Ocular Itching Change From Baseline to Day 6

Ocular itching was measured by subject on a scale of 0 to 4 where 0 = no itching and 4 = worst itching. This measurement was taken 7 minutes post CAC (NCT01730872)
Timeframe: 7 minutes post-CAC

Interventionscore on a scale (Mean)
Prednisolone-1.1
Placebo-1.0

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Inflammation Change From Baseline to Day 6

Ocular inflammation was measured by a masked clinician on a 4-point scale 90 minutes after the conjunctival allergen challenge (CAC) . 0 = best (little to no inflammation), 4 = worst (most inflammation). (NCT01730872)
Timeframe: 90 minutes post CAC

Interventionscore on a scale (Mean)
Prednisolone-1.2
Placebo-0.19

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Number of Participants With Change/Improvement Visual Acuity From the Beseline

Best corrected visual acuity will measure at 1,2,3 days, 1 week, 2 weeks and 1 month and at least 3 months after treatment. Improvement is defined based on 1) mean logMAR[12], 2) 0.3 change in logMAR (improvement, deterioration, and no change) [12,16] , 3) mean improvement percentage which is calculated as: improvement%= (logMar ( of VA after treatment)-logMar ( of initial VA))/(logMar(20/13)˟-logMar ( of initial VA) 4) percentage of patients at different ordinal categorization of the BCVA as no light perception (NLP), light perception (LP)and hand motion (HM), count fingers (CF), and ≥ 20/200. (NCT01783847)
Timeframe: Change from baseline at least 3 months after treatment

InterventionParticipants (Count of Participants)
Recombinant Human Erythropoietin (EPO)28
Methylprednisolone3
Observation5

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Number of Participants With Relative Afferent Papillary Defect (RAPD) Grade +4

A positive RAPD means there are differences between the two eyes in the afferent pathway due to retinal or optic nerve disease. Graded from +1 to +4. The higher one is a better grade (NCT01783847)
Timeframe: Change from baseline at least 3 months after treatment

InterventionParticipants (Count of Participants)
Recombinant Human Erythropoietin (EPO)26
Methylprednisolone7
Observation8

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MELD Score at 90 Days

"Model of End Stage Liver Disease Score calculated from serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR). MELD score ranges from 6-40. A higher score indicates a lesser outcome.~The Model for End Stage Liver Disease scoring system is based on the INR, total serum bilirubin and serum creatinine. The measure reflects 90 day prognosis of alcohol associated liver disease from the time of measurement and therefore can only be assessed on subjects who are alive at the specified time point since lab values from that time point are required for the measure." (NCT01809132)
Timeframe: 90 Days

Interventionscore on a scale (Mean)
Anakinra & Pentoxifylline & Zinc Sulfate15.50
Methylprednisolone16.38

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MELD Score at 28 Days

"Model of End Stage Liver Disease Score calculated from serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR). MELD score ranges from 6-40. A higher score indicates a lesser outcome.~The Model for End Stage Liver Disease scoring system is based on the INR, total serum bilirubin and serum creatinine. The measure reflects 90 day prognosis of alcohol associated liver disease from the time of measurement and therefore can only be assessed on subjects who are alive at the specified time point since lab values from that time point are required for the measure." (NCT01809132)
Timeframe: 28 days

Interventionscore on a scale (Mean)
Anakinra & Pentoxifylline & Zinc Sulfate22.57
Methylprednisolone20.95

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180 Days Mortality

Death at 180 days (NCT01809132)
Timeframe: Time to event up to 6 months

InterventionParticipants (Count of Participants)
Anakinra & Pentoxifylline & Zinc Sulfate17
Methylprednisolone22
Observational0

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MELD Score at 180 Days

"Model of End Stage Liver Disease Score calculated from serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR). MELD score ranges from 6-40. A higher score indicates a lesser outcome.~The Model for End Stage Liver Disease scoring system is based on the INR, total serum bilirubin and serum creatinine. The measure reflects 90 day prognosis of alcohol associated liver disease from the time of measurement and therefore can only be assessed on subjects who are alive at the specified time point since lab values from that time point are required for the measure." (NCT01809132)
Timeframe: 180 Days

Interventionscore on a scale (Mean)
Anakinra & Pentoxifylline & Zinc Sulfate15.81
Methylprednisolone11.85

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Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit

(NCT01853072)
Timeframe: Day 7 up to any visit through Day 90

Interventionpercentage of participants (Number)
Nepafenac9.1
Vehicle15.3

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Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit [Time Frame: Day 7 up to Any Visit]

(NCT01853072)
Timeframe: Day 7 up to any visit through Day 90

Interventionpercentage of participants (Number)
Nepafenac15.4
Vehicle27.3

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Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)

Macular edema was defined as ≥ 30% Increase from pre-operative baseline in central subfield macular thickness, as measured with Spectral Domain Ocular Coherence Tomography (SD-OCT). One eye (study eye) contributed to the analysis. (NCT01853072)
Timeframe: Day 0 to Day 90

InterventionPercentage of participants (Number)
Nepafenac2.3
Vehicle17.3

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Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60

(NCT01853072)
Timeframe: Baseline to Day 60

InterventionPercentage of participants (Number)
Nepafenac76.2
Vehicle64.7

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Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90

(NCT01853072)
Timeframe: Baseline to Day 90

InterventionPercentage of participants (Number)
Nepafenac77.2
Vehicle67.7

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Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90

BCVA (with spectacles or other visual corrective devices) was reported in letters read correctly, using the Early Treatment Diabetic Retinopathy Study (ETDRS) test of 70 letters. Improvement of BCVA was defined as an increase (gain) in the number of letters read, compared to the baseline assessment. One eye (study eye) contributed to the analysis. (NCT01853072)
Timeframe: Baseline to Day 14, and maintained through Day 90

InterventionPercentage of participants (Number)
Nepafenac61.7
Vehicle43.0

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Intraocular Pressure

Number of eyes in which the absolute intraocular pressure equaled or exceeded 24 mm Hg OR in which there was a relative increase of at least 10 mm Hg over the baseline preoperative reading. (NCT01853696)
Timeframe: from 1 to 12 months after transplant

Interventioneyes (Number)
Loteprednol11
Prednisolone Acetate27

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Immunologic Graft Rejection Episode

Rejection episodes were assessed by slit lamp examination and categorized as definite when an endothelial rejection line was detected in a previously clear graft, probable when inflammation (stromal infiltrate, keratic precipitates, cells in the anterior chamber, or ciliary injection) was detected in a previously clear graft without an endothelial rejection line, and possible if central corneal pachymetry increased by 30 microns or more, even if the cornea was clear and no inflammation was detected by slit lamp examination. (NCT01853696)
Timeframe: within first year after cornea transplantation

Interventioneyes (Number)
Loteprednol0
Prednisolone Acetate0

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Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit

(NCT01872611)
Timeframe: Day 7 up to any visit through Day 90

Interventionpercentage of participants (Number)
Nepafenac10.7
Vehicle8.9

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Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90

BCVA (with spectacles or other visual corrective devices) was reported in letters read correctly, using the Early Treatment Diabetic Retinopathy Study (ETDRS) test of 70 letters. Improvement of BCVA was defined as an increase (gain) in the number of letters read, compared to the baseline assessment. One eye (study eye) contributed to the analysis. (NCT01872611)
Timeframe: Baseline to Day 14, and maintained through Day 90

InterventionPercentage of participants (Number)
Nepafenac48.8
Vehicle50.5

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Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90

(NCT01872611)
Timeframe: Baseline to Day 90

InterventionPercentage of participants (Number)
Nepafenac65.4
Vehicle65.9

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Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60

(NCT01872611)
Timeframe: Baseline to Day 60

InterventionPercentage of participants (Number)
Nepafenac68.9
Vehicle62.1

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Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)

Macular edema was defined as ≥ 30% Increase from pre-operative baseline in central subfield macular thickness, as measured with Spectral Domain Ocular Coherence Tomography (SD-OCT). One eye (study eye) contributed to the analysis. (NCT01872611)
Timeframe: Day 0 to Day 90

InterventionPercentage of participants (Number)
Nepafenac5.9
Vehicle14.3

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Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit

(NCT01872611)
Timeframe: Day 7 up to any visit through Day 90

Interventionpercentage of participants (Number)
Nepafenac18.7
Vehicle16.7

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To Assess Post Donor Lymphocyte Infusion (DLI) Chimerism

To assess the number of Participants with 100% donor chimerism at 6 months post donor lymphocyte infusion (DLI) (NCT01875237)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Transplant Only0
Transplat Plus DLI1

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To Assess the Incidence of Acute GvHD Flare After CR/PR Requiring Additional Agent for Systemic Therapy Before Day 56 Post-administration of AP1903.

"To assess participants with incidence of acute GvHD flare after CR/PR requiring additional agent (including 2.5 mg/kg/day of prednisone [or methylprednisolone equivalent of 2 mg/kg/day]) for systemic therapy before Day 56 post-administration of AP1903." (NCT01875237)
Timeframe: before Day 56 post AP1903

InterventionParticipants (Count of Participants)
Transplant Only0
Transplat Plus DLI1

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To Assess the Incidence of Epstein-Barr Virus -PTLD or EBV Reactivation Requiring Therapy Post DLI.

To assess the incidence of Epstein-Barr virus (EBV)-associated lymphoproliferative disorder or EBV reactivation requiring therapy post DLI. (NCT01875237)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Transplant Only0
Transplat Plus DLI1

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To Evaluate the Safety of Donor Lymphocyte Infusion Followed by Dimerizer Drug, AP1903 by Number of Participants With Adverse Events.

To evaluate the safety of the infusion of inducible caspase 9 (BPZ-1001) modified T-cells followed by dimerizer drug, AP1903. Safety evaluated by number of participants with Adverse events. (NCT01875237)
Timeframe: up to 3.5 years

InterventionParticipants (Count of Participants)
Transplant Only0
Transplat Plus DLI1

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Number of Participants Assessed Post Donor Lymphocyte Infusion (DLI): Disease-free Survival & Non-relapse Mortality, Chimerism and GVHD.

Participants to assess at 6 months post donor lymphocyte infusion (DLI): disease-free survival & non-relapse mortality, chimerism and GVHD (NCT01875237)
Timeframe: 6 months

,
InterventionParticipants (Count of Participants)
disease-free survivaIchimerism post DLIGVHD post DLInon-relapse mortality
Transplant Only0000
Transplat Plus DLI1110

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To Assess the Incidence of GvHD Treatment Failure Post-administration of AP1903.

To assess the incidence of GvHD treatment failure, defined as no response, progression, administration of additional therapy for GvHD, or mortality post-administration of AP1903. (NCT01875237)
Timeframe: Day 3, 7, 14, 28, and 56 post-administration of AP1903.

,
InterventionParticipants (Count of Participants)
Day 3 post-administration of AP1903.Day 7 post-administration of AP1903.Day 14 post-administration of AP1903.Day 28 post-administration of AP1903.Day 56 post-administration of AP1903.
Transplant Only00000
Transplat Plus DLI11111

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To Assess the Proportion of Patients Developing Grade I-IV Acute GvHD

To assess the proportion of patients developing grade I-IV acute GvHD by Day 28, 56, and 180 post DLI. (NCT01875237)
Timeframe: Day 28, 56, and 180 post DLI.

,
InterventionParticipants (Count of Participants)
Day 28Day 56Day 180
Transplant Only000
Transplat Plus DLI110

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To Assess the Proportions of GvHD Response Post-administration of AP1903.

To assess the proportions of GvHD complete response (CR), partial response (PR), mixed response, no response, and progression among surviving patients at Day 3, 7, 14, 28, and 56 post-administration of AP1903. (NCT01875237)
Timeframe: Day 3, 7, 14, 28, and 56 post-administration of AP1903

InterventionParticipants (Count of Participants)
Day 3 post-administration of AP190371985950Day 3 post-administration of AP190371985951Day 7 post-administration of AP190371985951Day 7 post-administration of AP190371985950Day 14 post-administration of AP190371985951Day 14 post-administration of AP190371985950Day 28 post-administration of AP190371985951Day 28 post-administration of AP190371985950Day 56 post-administration of AP190371985951Day 56 post-administration of AP190371985950
no responsecomplete responseprogressionpartial response
Transplat Plus DLI1
Transplat Plus DLI0
Transplant Only0

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Duration of Response for Tazemetostat as a Single Agent or in Combination With Prednisolone (Phase 2 Only)

The time (in months) from the date of the initial response (CR or PR, whichever was first) until the date of the first documented disease progression per an Independent Review Committee (for Groups 1 and 2), per Investigator (Group 3), or death due to any cause. Patients who were alive and progression free at the time of the analysis were censored at the last date where the patient was known to be in response. Note: the DOR was censored, meaning data collection was stopped early for analysis, making the top limit of the 95% confidence interval not estimable (NE). Per RECIST v.1.0, CR was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be <10 mm in the short axis. The PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. (NCT01897571)
Timeframe: Radiologic tumor assessments performed at baseline (within 28 days before start of study treatment) and every 8 weeks during Cycles 2 to 6, and then every 12 weeks thereafter until confirmed PD/death, a maximum of approximately 82 months

Interventionmonths (Median)
Phase 2 Group 1: Tazemetostat in R/R FL With Mutant EZH211.3
Phase 2 Group 2: Tazemetostat in R/R FL With Wild-Type EZH213.0
Phase 2 Group 3: Tazemetostat in R/R DLBCL Monotherapy5.8
Phase 2 Group 4: Tazemetostat + Prednisone in R/R DLBCL Combination Therapy5.7

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Objective Response Rate (ORR; Complete Response + Partial Response [CR + PR]) (Phase 2)

Number of patients achieving an objective response (CR or PR)/number of patients treated x 100%. ORR was calculated as the percentage of patients with a confirmed complete response (CR) or partial response (PR) relative to the total number of patients in the analysis population per response evaluation criteria in solid tumors (RECIST) version (v)1.1. Complete Response (CR) was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. (NCT01897571)
Timeframe: Radiologic tumor assessments performed at baseline(within 28 days before start of study treatment)and every 8 weeks during Cycles 2 to 6,and then every 12 weeks thereafter until confirmed disease progression (PD)/death,a maximum of approximately 82 months

InterventionParticipants (Count of Participants)
Phase 2 Group 1: Tazemetostat in R/R FL With Mutant EZH234
Phase 2 Group 2: Tazemetostat in R/R FL With Wild-Type EZH219
Phase 2 Group 3: Tazemetostat in R/R DLBCL Monotherapy30
Phase 2 Group 4: Tazemetostat + Prednisolone in R/R DLBCL Combination Therapy8

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Progression Free Survival for Tazemetostat as a Single Agent or in Combination With Prednisolone (Phase 2 Only)

The time (in months) from the date of first dose of tazemetostat until the earliest date of disease progression or death from any cause. Per RECIST v1.0, CR was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be <10 mm in the short axis. The PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. (NCT01897571)
Timeframe: Radiologic tumor assessments performed at baseline (within 28 days before start of study treatment) and every 8 weeks during Cycles 2 to 6, and then every 12 weeks thereafter until confirmed PD/death, a maximum of approximately 82 months

Interventionmonths (Median)
Phase 2 Group 1: Tazemetostat in R/R FL With Mutant EZH213.8
Phase 2 Group 2: Tazemetostat in R/R FL With Wild-Type EZH211.1
Phase 2 Group 3: Tazemetostat in R/R DLBCL Monotherapy1.9
Phase 2 Group 4: Tazemetostat + Prednisolone in R/R DLBCL Combination Therapy1.8

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Ocular Burning Sensation, Ocular Discharge, Ocular Redness, Ocular Itching, Foreign Body Sensation

Ocular burning sensation, ocular discharge, ocular redness, ocular Itching, and foreign body sensation were measured to evaluate the safety and tolerability of topical tacrolimus 0.05% twice a day in the treatment of patients with ocular GVHD. Safety and tolerability of topical tacrolimus 0.05% twice a day will be monitored by the occurrence of systemic and ocular adverse events in addition to symptoms directly related to the instillation or use of the investigational medication. Subjects will be monitored at each study visit for the occurrence of any adverse events found through examination or patient reports. Tolerability will be evaluated at every visit with a self-response questionnaire that assessed burning sensation, discharge, redness, itchiness, and foreign body sensation on a scale from 0 to 4 (none = 0, trace = 1, mild = 2, moderate = 3, and severe = 4). Where a higher value represents more symptoms (less tolerability). (NCT01977781)
Timeframe: 10 weeks

,
Interventionunits on a scale (Mean)
Ocular Burning SensationOcular DischargeOcular RednessOcular ItchingForeign Body Sensation
Methylprednisolone Sodium Succinate2.230.260.430.600.57
Tacrolimus3.500.161.250.500.70

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Corneal Epitheliopathy (Corneal Fluorescein Staining Using the NEI Grading Scheme)

Corneal fluorescein staining is used to assess the level of corneal epitheliopathy that is related to dry eye disease. The corneal fluorescein staining scale ranges from 0 to 15, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of epitheliopathy. (NCT01977781)
Timeframe: 10 weeks

Interventionunits on a scale (Mean)
Tacrolimus3.7
Methylprednisolone Sodium Succinate6.6

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Intraocular Pressure

Intraocular pressure is the measure of the fluid pressure within the eye as measured by tonometry. Intraocular pressure is normally measured in millimeters of mercury (mmHg). The normal range for intraocular pressure is 12-20 mmHg, there is no better or worse measurement. (NCT01977781)
Timeframe: 10 weeks

Interventionmillimeters of mercury (mmHg) (Mean)
Tacrolimus16.5
Methylprednisolone Sodium Succinate17.1

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Visual Acuity

Visual acuity is measured by asking subjects to read letters on a chart that consists of different rows of letters. Each row of letters corresponds to different levels of visual acuity. The Logarithm of the Minimum Angle of Resolution (LogMAR) scale generally ranges from 0 to 1, with 0 corresponding to 20/20 vision and 1 corresponding to 20/200 vision. The range from 0-1 is not absolute, however, as patients who have vision better than 20/20 or vision worse than 20/200 will score out side of the 0 to 1 range. (NCT01977781)
Timeframe: 10 weeks

InterventionLogMAR Scale (Mean)
Tacrolimus0.13
Methylprednisolone Sodium Succinate0.13

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Tear Film Break-Up Time

Tear Film Break-Up Time measures the amount of time, in seconds, that the tear film completely coats the ocular surface after each blink. The longer the amount of time the tear film completely coats the ocular surface is considered to be better than a shorter amount of time. (NCT01977781)
Timeframe: 10 weeks

InterventionSeconds (Mean)
Tacrolimus2.6
Methylprednisolone Sodium Succinate1.0

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Ocular Surface Disease Index (OSDI) Questionnaire

The OSDI questionnaire is a 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate each of the dry eye symptoms on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms. (NCT01977781)
Timeframe: 10 weeks

Interventionunits on a scale (Mean)
Tacrolimus42
Methylprednisolone Sodium Succinate28

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Schirmer Tear Test (mm)

Schirmer tear test measures the amount of tear secretion produced by a patient in millimeters (mm). Generally, the greater amounts of tear secretion is better than smaller amounts of tear secretion. The minimum value of this scale is 0 mm of tear secretion and there is no maximum value to this scale. (NCT01977781)
Timeframe: 10 weeks

Interventionmillimeter (mm) (Mean)
Tacrolimus3.5
Methylprednisolone Sodium Succinate3.5

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Change From Baseline Disease Activity Score Based on 28-Joint Count (DAS28) at Week 24

DAS28 was calculated from the number of swollen joints and painful joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant-rated arthritis activity assessment using visual analog scale [VAS]) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity. (NCT02006706)
Timeframe: Baseline, Week 24

Interventionscore on a scale (Mean)
Rituximab/Methylprednisolone/MTX2.98

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Health Assessment Questionnaire-Disability Index (HAQ-DI)

HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. (NCT02006706)
Timeframe: Baseline, Week 24

Interventionscore on a scale (Mean)
BaselineWeek 24
Rituximab/Methylprednisolone/MTX1.911.05

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QALYS at 12 Months (Cross-walk Tariff)

"The Quality Adjusted Life Years (QALYs) is a measure of the state of health of a person/group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to 1 year of life in perfect health. QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment/intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale). It is often measured in terms of the person's ability to carry out the activities of daily life and freedom from pain and mental disturbance. The QALY does not have a maximum score.~Cross-walk tariff: Crosswalk value sets were developed from a study of respondents who completed both the EQ-5D-3L and EQ-5D-5L. The crosswalk used a non-parametric response mapping method to predict values that are linked to the EQ-5D-3L value set. In short, the cross-walk tariff maps EQ-5D-5L values." (NCT02038452)
Timeframe: 12 months

Interventionscore on a scale (Mean)
Steroid Injection0.723
Wrist Splint0.736

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BCTQ Symptom Severity and Functional Limitations 6 Weeks (Subgroup Analysis (SG), Intervention of Their Preference)

Subgroup analysis was performed in patients who were allocated the intervention of their preference. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection1.88
Wrist Splint2.19

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BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Preferred Splint)

Subgroup analysis was performed in patients who preferred splint. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection2.15
Wrist Splint2.40

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BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Preferred Injection)

Subgroup analysis was performed in patients who preferred injection. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection1.88
Wrist Splint2.40

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BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Did Not State a Preference of Intervention)

Subgroup analysis was performed in patients who did not state a preference of intervention. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection2.03
Wrist Splint2.26

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BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Did Not Receive the Intervention of Their Preference)

Subgroup analysis was performed in patients who did not receive the intervention of their preference. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection2.15
Wrist Splint2.40

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BCTQ Symptom Severity and Functional Limitations 6 Weeks (Per-Protocol Analysis (PP))

Per protocol analysis for comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection1.96
Wrist Splint2.28

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BCTQ Symptom Severity and Functional Limitations 6 Weeks (Complete Case Analysis (CC))

Sensitivity analysis for comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection1.95
Wrist Splint2.29

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Hand-wrist Pain Intensity Over 24 Months: 6 Weeks

Comparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 0-10, higher score indicates more pain. Results are presented at 6 weeks. (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection3.33
Wrist Splint4.28

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BCTQ Symptom Severity and Functional Limitations 6 Months (PP)

Per protocol analysis for comparison of overall BCTQ between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection2.09
Wrist Splint2.02

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BCTQ Symptom Severity and Functional Limitations 6 Months (CC)

Sensitivity analysis for comparison of overall BCTQ between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection2.08
Wrist Splint2.04

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BCTQ Symptom Severity and Functional Limitations 6 Months

Comparison of overall BCTQ between treatment groups at 6 months follow-up (1-5 scale, higher score indicates more severe symptoms and functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection2.15
Wrist Splint2.06

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BCTQ Functional Limitations Subscale 6 Weeks (PP)

"Per protocol analysis for comparison of BCTQ functional limitations between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more functional impairment) on participants with complete data.~BCTQ: Boston Carpal Tunnel Questionnaire" (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection1.88
Wrist Splint2.06

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Symptom Severity and Limitations in Hand Function as Assessed by the BCTQ 6 Weeks

Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection2.02
Wrist Splint2.29

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Secondary: BCTQ Symptom Severity and Functional Limitations Over 24 Months: 24 Months

Comparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 1-5, higher score indicates more severe symptoms and functional impairment. Results are presented at 24 months. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 24 months

Interventionscore on a scale (Mean)
Steroid Injection1.79
Wrist Splint1.73

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QALYS at 6 Months (Cross-walk Tariff)

"The Quality Adjusted Life Years (QALYs) is a measure of the state of health of a person/group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to 1 year of life in perfect health. QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment/intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale). It is often measured in terms of the person's ability to carry out the activities of daily life and freedom from pain and mental disturbance. The QALY does not have a maximum score.~Cross-walk tariff: Crosswalk value sets were developed from a study of respondents who completed both the EQ-5D-3L and EQ-5D-5L. The crosswalk used a non-parametric response mapping method to predict values that are linked to the EQ-5D-3L value set. In short, the cross-walk tariff maps EQ-5D-5L values." (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection0.354
Wrist Splint0.356

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QALYS at 24 Months (Cross-walk Tariff)

"The Quality Adjusted Life Years (QALYs) is a measure of the state of health of a person/group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to 1 year of life in perfect health. QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment/intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale). It is often measured in terms of the person's ability to carry out the activities of daily life and freedom from pain and mental disturbance. The QALY does not have a maximum score.~Cross-walk tariff: Crosswalk value sets were developed from a study of respondents who completed both the EQ-5D-3L and EQ-5D-5L. The crosswalk used a non-parametric response mapping method to predict values that are linked to the EQ-5D-3L value set. In short, the cross-walk tariff maps EQ-5D-5L values." (NCT02038452)
Timeframe: 24 months

Interventionscore on a scale (Mean)
Steroid Injection1.461
Wrist Splint1.497

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BCTQ Functional Limitations Subscale 6 Weeks

Comparison of BCTQ functional limitations between treatment groups at 6 weeks follow-up (1-5 scale, higher score indicates more severe functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection1.88
Wrist Splint2.09

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NHS Cost Differences at 6 Months (CC)

Complete case analysis on the cost of interventions at 6 months (NCT02038452)
Timeframe: 6 months

InterventionUK Pounds (Mean)
Steroid Injection353.48
Wrist Splint306.42

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NHS Cost Differences at 6 Months

Cost of interventions at 6 months (NCT02038452)
Timeframe: 6 months

InterventionUK Pounds (Mean)
Steroid Injection346.78
Wrist Splint313.24

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NHS Cost Differences at 24 Months

Cost of interventions at 24 months (NCT02038452)
Timeframe: 24 months

InterventionUK Pounds (Mean)
Steroid Injection657.87
Wrist Splint586.77

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NHS Cost Differences at 12 Months

Cost of interventions at 12 months (NCT02038452)
Timeframe: 12 months

InterventionUK Pounds (Mean)
Steroid Injection508.69
Wrist Splint395.54

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Hand-wrist Pain Intensity Over 24 Months: 6 Months

Comparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 0-10, higher score indicates more pain. Results are presented at 6 months. (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection4.11
Wrist Splint3.29

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Hand-wrist Pain Intensity Over 24 Months: 24 Months

Comparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 0-10, higher score indicates more pain. Results are presented at 24 months. (NCT02038452)
Timeframe: 24 months

Interventionscore on a scale (Mean)
Steroid Injection2.81
Wrist Splint2.40

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Hand-wrist Pain Intensity Over 24 Months: 12 Months

Comparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 0-10, higher score indicates more pain. Results are presented at 12 months. (NCT02038452)
Timeframe: 12 months

Interventionscore on a scale (Mean)
Steroid Injection3.17
Wrist Splint3.14

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Hand-wrist Pain Intensity 6 Weeks (PP)

Per protocol analysis for comparison of pain scores between treatment groups at 6 weeks follow-up (higher score indicates more pain) on participants with complete data. (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection3.33
Wrist Splint4.44

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Hand-wrist Pain Intensity 6 Weeks (CC)

Sensitivity analysis for comparison of pain scores between treatment groups at 6 weeks follow-up (scale 0-10, higher score indicates more pain) on participants with complete data. (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection3.33
Wrist Splint4.28

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Hand-wrist Pain Intensity 6 Weeks

Comparison of pain scores between treatment groups at 6 weeks follow-up (0-10 scale, higher score indicates more pain). (NCT02038452)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Steroid Injection3.42
Wrist Splint4.28

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Hand-wrist Pain Intensity 6 Months (PP)

Per protocol analysis for comparison of pain scores between treatment groups at 6 months follow-up (scale 0-10, higher score indicates more pain) on participants with complete data. (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection4.11
Wrist Splint3.38

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Hand-wrist Pain Intensity 6 Months (CC)

Sensitivity analysis for comparison of pain scores between treatment groups at 6 months follow-up (scale 0-10, higher score indicates more pain) on participants with complete data. (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection4.11
Wrist Splint3.29

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Hand-wrist Pain Intensity 6 Months

Comparison of pain scores between treatment groups at 6 months follow-up. 0-10 scale, higher score indicates more pain. (NCT02038452)
Timeframe: 6 months

Interventionunits on a scale (Mean)
Steroid Injection4.32
Wrist Splint3.46

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BCTQ Symptom Severity Subscale 6 Weeks (PP)

"Per protocol analysis for comparison of BCTQ symptom severity between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms) on participants with complete data. BCTQ:~Boston Carpal Tunnel Questionnaire" (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection2.07
Wrist Splint2.44

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BCTQ Symptom Severity Subscale 6 Weeks (CC)

"Sensitivity analysis for comparison of BCTQ symptom severity between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms) on participants with complete data. BCTQ:~Boston Carpal Tunnel Questionnaire" (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection2.07
Wrist Splint2.44

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BCTQ Symptom Severity and Functional Limitations Over 24 Months: 6 Weeks

Comparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 1-5, higher score indicates more severe symptoms and functional impairment. Results are presented at 6 weeks. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection1.95
Wrist Splint2.30

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BCTQ Symptom Severity Subscale 6 Months (PP)

"Per protocol analysis for comparison of BCTQ symptom severity between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more severe symptoms) on participants with complete data. BCTQ:~Boston Carpal Tunnel Questionnaire" (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection2.28
Wrist Splint2.15

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BCTQ Symptom Severity Subscale 6 Months (CC)

"Sensitivity analysis for comparison of BCTQ symptom severity between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more severe symptoms) on participants with complete data. BCTQ:~Boston Carpal Tunnel Questionnaire" (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection2.29
Wrist Splint2.16

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BCTQ Functional Limitations Subscale 6 Weeks (CC)

Sensitivity analysis for comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection1.86
Wrist Splint2.10

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BCTQ Symptom Severity and Functional Limitations Over 24 Months: 12 Months

Comparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 1-5, higher score indicates more severe symptoms and functional impairment). Results are presented at 12 months. BCTQ: Boston Carpal Tunnel Questionnaire. (NCT02038452)
Timeframe: 12 months

Interventionscore on a scale (Mean)
Steroid Injection1.98
Wrist Splint2.05

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BCTQ Symptom Severity and Functional Limitations Over 24 Months: 6 Months

Comparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up. Scale 1-5, higher score indicates more severe symptoms and functional impairment. Results are presented at 6 months. BCTQ: Boston Carpal Tunnel Questionnaire. (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection2.08
Wrist Splint2.04

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BCTQ Symptom Severity Subscale 6 Weeks

Comparison of BCTQ symptom severity between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms). BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection2.12
Wrist Splint2.43

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BCTQ Functional Limitations Subscale 6 Months

Comparison of BCTQ functional limitations between treatment groups at 6 months follow-up (1-5 scale, higher score indicates more functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection1.91
Wrist Splint1.89

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BCTQ Functional Limitations Subscale 6 Months (CC)

Sensitivity analysis for comparison of BCTQ function limitations between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection1.85
Wrist Splint1.88

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BCTQ Functional Limitations Subscale 6 Months (PP)

Per protocol analysis for comparison of BCTQ functional limitations between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection1.89
Wrist Splint1.84

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BCTQ Symptom Severity Subscale 6 Months

Comparison of BCTQ symptom severity between treatment groups at 6 months follow-up (1-5 scale, higher score indicates more severe symptoms). BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection2.33
Wrist Splint2.18

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Percentages of Patients With Early Response Defined as no Slow Responding Lesions (SRL) and no Progressive Disease (PD) at Any Disease Sites Determined by Positron Emission Tomography (PET) Per Deauville Criteria Through Central Review

The percentages of patients (with available PET scan) with no SRL and no PD will be compared between the two randomized arms to see if brentuximab vedotin in the chemotherapy backbone of doxorubicin hydrochloride, vincristine sulfate, etoposide, prednisone and cyclophosphamide (Bv-AVEPC) arm has a higher rate of early response compared to doxorubicin hydrochloride, bleomycin sulfate, vincristine sulfate, etoposide, prednisone, and cyclophosphamide (ABVE-PC) arm. Two-sample Z test of proportions at 1-sided alpha level of 0.05 will be used for these comparisons. (NCT02166463)
Timeframe: After 42 days of chemotherapy

InterventionPercentage of patients (Number)
Arm I (ABVE-PC)80.7
ARM II (Bv-AVEPC)81.2

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Event Free Survival (EFS), Where Events Include Disease Progression or Relapse, Second Malignancy, or Death

Primary analysis will be based 1-sided log rank test comparison of EFS curves between the 2 randomized arms per intention-to-treat principle. Progression is defined as an ≥50% increase of in the product of the perpendicular diameters of any of the involved nodes or nodal masses or focal organ lesions in sites that were persistently PET positive; or recurrent PET positive lesions (Deauville 4, 5) in sites that had previously been PET negative regardless of change of size, as was the development of new PET avid measurable lesion(s) >1.5cm in any axis, or new sites of assessable disease. Relapse is defined in patients who achieved a prior CR but subsequently has an increase of ≥50% of the PPD in prior nodal or extranodal sites in a recurrently PET positive lesion(s), or the development of new measurable lesion(s) >1.5cm in any axis, or new sites of assessable disease. Second malignancy is defined based on report of a cancer that is not considered to be classic Hodgkin Lymphoma. (NCT02166463)
Timeframe: Up to 48 months after the last enrollment

Interventionpercentage of participants (Number)
Arm I (ABVE-PC)82.5
ARM II (Bv-AVEPC)92.1

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Percentages of Patients Experiencing Grade 3+ Peripheral Neuropathy Assessed by Modified Balis Scale

"The percentages of patients experiencing grade 3+ peripheral neuropathy assessed by the treating clinician using the modified Balis scale. The Modified Balis scale of Pediatric Neuropathy allows clinicians to assign a score for sensory or motor neuropathy symptoms separately. Scores range from 1 to 4 with 1 being the least symptomatic state and 4 indicating a severe debility. The percentages of patients (with a score >/=3) will be compared between the 2 arms by two-sample Z test at 1-sided alpha level of 0.05." (NCT02166463)
Timeframe: From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years.

InterventionPercentage of patients (Number)
Arm I (ABVE-PC)5.5
ARM II (Bv-AVEPC)6.7

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Bayley III Gross Motor Scaled Score (Change From Baseline to 12 Month)

Bayley III Gross Motor Scaled Score measures motor development. This is normed for typically developing children and follow a bell shaped curve. The scale has mean of 10 +/-3 for children at all ages and is bell shaped. Therefore the two standard deviation range is 16 to 4 with higher values indicated better performance. Lower values have been shown to be common in boys with DMD and it this study the baseline average score was 4.2. (NCT02167217)
Timeframe: One year

Interventionunits on a scale (Mean)
Oral Prednisolone4.8

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Overall Survival (OS) Rate

Overall survival (OS) is defined from the date of natalizumab infusion to death or censored at last clinical evaluation. OS was estimated using the Kaplan-Meier method. (NCT02176031)
Timeframe: 2 years

Interventionpercentage of patients (Number)
Natalizumab43

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GVHD-free Survival Rate

Graft-versus-host disease (GVHD) free survival is defined as achieving complete response without death or relapse or requiring secondary immunosuppressive therapy . Proportions are reported descriptively. GVHD-free survival was assessed using the Kaplan-Meier method. (NCT02176031)
Timeframe: Day 56

Interventionpercentage of patients (Number)
Natalizumab33.3

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GI aGVHD Response Rate

Gastrointestinal (GI) acute graft-versus-host disease (GVHD) Response is defined by complete response, very good partial response, or partial response in signs and symptoms of GI aGVHD. (NCT02176031)
Timeframe: Day 28, Day 56

Interventionpercentage of patients (Number)
Overall response rate for GI GVHD at Day 28Overall response rate for GI GVHD at Day 56
Natalizumab5752

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Rate of GVHD Flares

Number of subjects who experienced graft-versus-host disease (GVHD) flares requiring therapy after initial complete response (CR) or partial response (PR) by day 28 after the first dose of Natalizumab. (NCT02176031)
Timeframe: by Day 28

InterventionParticipants (Count of Participants)
Natalizumab0

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Percentage Steroid Dose Was Reduced at Day 28, 56, and 100 in Comparison to Steroid Dose at First Administration of Natalizumab.

Median percentage steroid dose was reduced at Day 28, Day 56, and Day 100 in comparison to steroid dose at first administration of Natalizumab. (NCT02176031)
Timeframe: Day 28, 56, and 100

Interventionpercentage of steroid dose (Median)
Median reduction in steroid dose at day 28Median reduction in steroid dose at day 56Median reduction in steroid dose at day 100
Natalizumab427185

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Graft-verus-host Disease (GVHD) Response Rate

"Complete Response (CR) is defined as resolution of all signs and symptoms of acute GVHD.~Very Good Partial Response (VGPR) is defined by no rash or residual erythematous rash involving less than 25% of the body surface, and total serum bilirubin concentration less than 2 mg/dL or less than 25% of baseline at enrollment and tolerating food or enteral feeding, predominantly formed stools, no overt gastrointestinal bleeding or abdominal cramping, and no more than occasional nausea and vomiting.~Partial Response (PR) is defined as an improvement of one stage in one or more organs without progression in any other organ.~Non-response (NR) is defined as no reduction in any GVHD organ staging.~Progression is defined as either new organ involvement on day +8 or thereafter, or increased organ specific symptoms sufficient to increase the organ stage by one or more or the initiation of an additional GVHD agent.~Overall Response Rate (ORR) is the sum of CR, VGPR, and PR." (NCT02176031)
Timeframe: 28 Days, 56 Days

InterventionParticipants (Count of Participants)
Overall Response at Day 28Complete Response at Day 28Very Good Partial Response at Day 28Partial Response at Day 28Non-response/Progression of GVHD at Day 28Overall Response at Day 56Complete Response at Day 56Very Good Partial Response at Day 56Partial Response at Day 56Non-response/Progression of GVHD at Day 56
Natalizumab127237117226

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Number of Participants With Secondary Graft Failure

"The cumulative incidence of secondary graft failure will be estimated using the Kalbfleisch-Prentice method. Deaths due to toxicity and relapse before day 100 are the competing events.~Secondary graft failure or graft rejection will be defined as no evidence of donor chimerism by umbilical cord blood (UCB) and/or haploidentical donor (<10%), or too few cells to perform adequate chimerism analysis, in research participants with prior neutrophil engraftment.~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who experienced secondary graft failure is provided." (NCT02199041)
Timeframe: 100 days after transplantation

InterventionParticipants (Count of Participants)
Treatment0

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Number of Participants With Event-free Survival (EFS)

"The Kaplan-Meier estimate of EFS with relapse, death due to any cause and graft failure as events along with their standard errors will be calculated using the SAS macro (bmacro251-Excel2007kme) available in the Department of Biostatistics at St. Jude, where EFS = min (date of last follow-up, date of relapse, date of graft failure, date of death due to any cause) - date of transplant, and all participants surviving at the time of analysis without events will be censored. The number of participants who did not experience any of these events through one year post-transplant is given.~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who did not experience any events defined above is provided." (NCT02199041)
Timeframe: One year after transplantation

InterventionParticipants (Count of Participants)
Treatment4

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Number of Participants With Malignant Relapse

"Relapse was evaluated using standard World Health Organization (WHO) criteria for each disease. The estimate of cumulative incidence of relapse will be estimated using Kalbfleisch-Prentice method. Relapse defined as the recurrence of original disease. Death is the competing risk event. The analysis will be implemented using Statistical Analysis System (SAS) macro (bmacro252-Excel2007cin).~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who experienced malignant relapse is provided" (NCT02199041)
Timeframe: One year after transplantation

InterventionParticipants (Count of Participants)
Treatment7

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Number of Participants With Neutrophil Engraftment

Neutrophil engraftment is defined as absolute neutrophil count (ANC) recovery of ≥ 0.5 x 10^9/L (500/mm^3) for three consecutive laboratory values obtained on different days (derived from either donor). Date of engraftment is the date of the first of the three consecutive laboratory values. The number of patients engrafted by day +42 post-transplant is provided. (NCT02199041)
Timeframe: Until day 42 post-transplant

InterventionParticipants (Count of Participants)
Treatment11

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Number of Participants by Severity With Acute Graft Versus Host Disease (GVHD) in the First 100 Days After HCT

"Cumulative incidence of acute GVHD was estimated using Kalbfleisch-Prentice method. Death is the competing risk event. SAS macro (bmacro252-Excel2007cin) available at St. Jude was used for analysis. Severity of GVHD and stage were determined using the Clinical Oncology Group (COG) Stem Cell Committee Consensus Guidelines for establishing organ stage and overall grade of acute GVHD. Participants are graded on a scale from I to IV, with I being mild and IV being severe.~Overall Clinical Grade (based on the highest stage obtained):~Grade 0: No stage 1-4 of any organ. Grade I: Stage 1-2 skin and no liver or gut involvement. Grade II: Stage 3 skin, or Stage I liver involvement, or Stage 1 gastrointestinal (GI).~Grade III: Stage 0-3 skin, with Stage 2-3 liver, or Stage 2-3 GI. Grade IV: Stage 4 skin, liver or GI involvement.~Due to early close of study, a small number of patients were enrolled. The number of patients who experienced acute GVHD is provided." (NCT02199041)
Timeframe: 100 days after transplantation

InterventionParticipants (Count of Participants)
No Acute GVHDGrade IGrade IIGrade IIIGrade IV
Treatment80121

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Number of Participants by Severity With Chronic Graft Versus Host Disease (GVHD) in the First 100 Days After HCT

"Cumulative incidence of acute and chronic GVHD was estimated using Kalbfleisch-Prentice method. Death is competing risk event. SAS macro (bmacro252-Excel2007cin) available St. Jude was used for such analysis. Severity of chronic GVHD was evaluated using National Institutes of Health (NIH) Consensus Global Severity Scoring. Mild is considered a better outcome with severe being the worst.~Criteria for grading chronic GVHD:~Mild: 1-2 organs/sites, maximum organ score of 1, and lung score of 1. Moderate: 3 or more organs/sites and maximum organ score of 1 and lung score of 1, OR at least 1 organ/site and maximum organ score of 2 and lung score of 1. Severe: At least 1 organ/site and maximum organ score of 3 and lung score of 2-3.~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who experienced chronic GVHD is provided." (NCT02199041)
Timeframe: 100 days after transplantation

InterventionParticipants (Count of Participants)
No Chronic GVHDMildModerateSevere
Treatment11001

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Number of Participants With Overall Survival (OS)

"The Kaplan-Meier estimate of OS with relapse, death due to any cause and graft failure as events along with their standard errors will be calculated using the SAS macro (bmacro251-Excel2007kme) available in the Department of Biostatistics at St. Jude, where OS = min (date of last follow-up, date of death) - date of hematopoietic cell transplantation (HCT) and all participants surviving after 1 year post-transplant will be considered as censored.~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who did not die at 1 year post-transplant is provided." (NCT02199041)
Timeframe: One year after transplantation

InterventionParticipants (Count of Participants)
Treatment6

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Change in Subject Reported Shoulder Pain as Measured by the Visual Analogue Scale

Change in shoulder pain reported by the subject after injection at 6 weeks. The subject will report shoulder pain on a scale from 0 (no pain) to 10 (maximal pain) after injection. A 2 point change is expected. (NCT02242630)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Methylprednisolone, 20 mg1.0
Methylprednisolone, 40 mg1.8
Triamcinolone, 20 mg1.9
Triamcinolone, 40 mg1.8

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Change in Shoulder Function, as Measured by the QuickDASH ®

The primary outcome of this study will be to compare the dose and type of intrabursal corticosteroid received to improvements in a functional measure of the shoulder, the QuickDASH. The QuickDASH is a validated questionnaire of shoulder function consisting of 11 questions with a score from 100 (maximal dysfunction) to 0 (no dysfunction). It is expected that improvements will lead to at least a 10 point improvement (minimal clinically important difference) (NCT02242630)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Methylprednisolone, 20 mg19.2
Methylprednisolone, 40 mg21.3
Triamcinolone, 20 mg19.1
Triamcinolone, 40 mg24.7

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Ocular Surface Disease Index (OSDI)

A 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate one symptom on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms. (NCT02256969)
Timeframe: 4 week Time Point

Interventionunits on a scale (Mean)
Meibomian Gland Probing Plus Lubricant38.7
Sham Meibomian Gland Probing Plus Lubricant36.9
Meibomian Gland Probing Plus Blephamide37.3

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Corneal Fluorescein Staining (CFS)

Is used to assess the level of corneal epitheliopathy that is related to dry eye disease. The CFS scale ranges from 0 to 15 scale, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of epitheliopathy. (NCT02256969)
Timeframe: 4 week Time Point

Interventionunits on a scale (Mean)
Meibomian Gland Probing Plus Lubricant2.4
Sham Meibomian Gland Probing Plus Lubricant2.0
Meibomian Gland Probing Plus Blephamide1.4

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Tear Break Up Time (TBUT)

TBUT measures the amount of time, in seconds, a dry spot appears in the tear film after each blink. Values less than 10 seconds are considered abnormal. (NCT02256969)
Timeframe: 4 week Time Point

InterventionSeconds (Mean)
Meibomian Gland Probing Plus Lubricant3.5
Sham Meibomian Gland Probing Plus Lubricant4.2
Meibomian Gland Probing Plus Blephamide3.2

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Symptom Assessment in Dry Eye (SANDE)

A two-item survey used to assess the frequency and severity of dry eye disease. The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms. (NCT02256969)
Timeframe: 4 week Time Point

Interventionunits on a scale (Mean)
Meibomian Gland Probing Plus Lubricant49.1
Sham Meibomian Gland Probing Plus Lubricant50.2
Meibomian Gland Probing Plus Blephamide47.6

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Percentage of Participants With an Overall Response at Week 24, Week 48, and Week 96

"The percentage of participants who achieved an overall response, defined as meeting all of the following criteria:~>50% improvement in the urine protein-to-creatinine ratio (UPCR) from study entry, based on a 24-hour collection;~Estimated glomerular filtration rate (eGFR) ≥120 ml/min/1.73 m^2 calculated by the CKD-EPI formula or, if < 120 ml/min/1.73 m^2, then > 80% of eGFR at entry; and~Prednisone dose tapered to 10 mg/day and adherence to prednisone dosing provisions." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96

,
Interventionpercentage of participants (Number)
Week 24Week 48Week 96
Rituximab/Cyclophosphamide (RC)46.760.053.3
Rituximab/Cyclophosphamide/Belimumab (RCB)55.073.771.4

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Percentage of Participants With At Least One Grade 3 or Higher Infectious Adverse Event By Week 24, Week 48 and Week 96

"The percentage of participants who experienced at least one Grade 3 or higher treatment-emergent infectious adverse event. The severity of adverse events (AEs) was classified into grades using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03:June 14, 2010). Treatment-emergent AEs are those:~with an onset date on or after the first dose of study medication,~with onset before first dose but that worsened in severity after first dose, and~for which the start of the AE in relation to the start of study medication could not be established.~AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 17.0. Grade 3 or higher AEs were classified infectious based on the study team's review of the MedDRA body systems and preferred terms of the AEs." (NCT02260934)
Timeframe: Week 0 to Week 96

,
Interventionpercentage of participants (Number)
Week 0 to Week 24Week 0 to Week 48Week 0 to Week 96
Rituximab/Cyclophosphamide (RC)9.122.727.3
Rituximab/Cyclophosphamide/Belimumab (RCB)4.89.59.5

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Percentage of Participants With B Cell Reconstitution at Week 24, Week 48 and Week 96

"The percentage of participants who achieved B cell reconstitution, defined as a peripheral blood total B cell count ≥ to the baseline count or the lower limit of normal, whichever was lower. Note: B cell depletion was expected to occur in this study between Weeks 0 and 4, after initiation of rituximab and cyclophosphamide.~Normal peripheral blood B Cell count: 107 to 698 cells/µL." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96

,
InterventionPercentage of Participants (Number)
Week 24Week 48Week 96
Rituximab/Cyclophosphamide (RC)31.335.740.0
Rituximab/Cyclophosphamide/Belimumab (RCB)6.311.830.8

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Percentage of Participants With Grade 4 Hypogammaglobulinemia by Week 24, Week 48, and Week 96

The percentage of participants who experienced Grade 4 hypogammaglobulinemia, defined as having a serum Immunoglobulin G (IgG) level < 300 mg/dL. Severity of adverse events (AEs) was classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03:June 14, 2010). (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96

,
Interventionpercentage of participants (Number)
Week 0 to Week 24Week 0 to Week 48Week 0 to Week 96
Rituximab/Cyclophosphamide (RC)000
Rituximab/Cyclophosphamide/Belimumab (RCB)000

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Percentage of Participants Hypocomplementemic for Complement Component C4 at Week 24, Week 48, and Week 96

"The percentage of participants who were hypocomplementemic for complemen component C4, defined as a C4 level <10 mg/dL.~Serum C4 complement is a protein which can be measured in the blood. Low blood levels of C4 are common in those with active lupus." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96

,
Interventionpercentage of participants (Number)
Week 24Week 48Week 96
Rituximab/Cyclophosphamide (RC)19.015.016.7
Rituximab/Cyclophosphamide/Belimumab (RCB)5.015.011.1

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Percentage of Participants With Treatment Failure by Week 24, Week 48, and Week 96

The percentage of participants who met the criteria for treatment failure, defined by withdrawal from the protocol treatment regimen due to worsening nephritis, infection, or study medication toxicity. (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96

,
Interventionpercentage of participants (Number)
Week 0 to Week 24Week 0 to Week 48Week 0 to Week 96
Rituximab/Cyclophosphamide (RC)18.245.563.6
Rituximab/Cyclophosphamide/Belimumab (RCB)14.328.647.6

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Percentage of Participants With a Sustained Complete Response

"The percentage of participants who achieved a sustained complete response, defined as a complete response achieved at Week 48 and Week 96.~Complete response was defined as meeting all of the following criteria:~Urine protein-to-creatinine ratio (UPCR) < 0.5, based on a 24-hour collection;~Estimated glomerular filtration rate (eGFR) ≥120 ml/min/1.73 m^2 calculated by the CKD-EPI formula or, if < 120 ml/min/1.73 m^2, then > 80% of eGFR at entry; and~Prednisone dose tapered to 10 mg/day and adherence to prednisone dosing provisions." (NCT02260934)
Timeframe: Week 48, Week 96

Interventionpercentage of participants (Number)
Rituximab/Cyclophosphamide (RC)26.7
Rituximab/Cyclophosphamide/Belimumab (RCB)28.6

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Count of Participants: Frequency of Non-renal Flares by Week 24

"Count of participants who experienced non-renal flares, defined as any new A finding in a non-renal organ system in the British Isles Lupus Assessment Group (BILAG) assessment. A BILAG A finding represents a significant increase in, or a new manifestation of, disease activity." (NCT02260934)
Timeframe: Week 24

,
InterventionParticipants (Count of Participants)
0 Non-renal flares1 Non-renal flare2 Non-renal flares
Rituximab/Cyclophosphamide (RC)2110
Rituximab/Cyclophosphamide/Belimumab (RCB)2001

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Count of Participants: Frequency of Non-renal Flares by Week 48

"Count of participants who experienced non-renal flares, defined as any new A finding in a non-renal organ system in the British Isles Lupus Assessment Group (BILAG) assessment. A BILAG A finding represents a significant increase in, or a new manifestation of, disease activity." (NCT02260934)
Timeframe: Week 48

,
InterventionParticipants (Count of Participants)
0 Non-renal flares1 Non-renal flares2 Non-renal flare
Rituximab/Cyclophosphamide (RC)2020
Rituximab/Cyclophosphamide/Belimumab (RCB)2001

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Count of Participants: Frequency of Non-renal Flares by Week 96

"Count of participants who experienced non-renal flares, defined as any new A finding in a non-renal organ system in the British Isles Lupus Assessment Group (BILAG) assessment. A BILAG A finding represents a significant increase in, or a new manifestation of, disease activity." (NCT02260934)
Timeframe: Week 96

,
InterventionParticipants (Count of Participants)
0 Non-renal flares1 Non-renal flare2 Non-renal flares
Rituximab/Cyclophosphamide (RC)1840
Rituximab/Cyclophosphamide/Belimumab (RCB)1911

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Frequency of Specific Adverse Events of Interest By Event by Week 96

"Number of ≥ Grade 2 specific treatment-emergent adverse events (AEs) of interest. Grade 2 or higher AEs were classified according to the listed categories of interest based on the study team's review of the AEs.~Treatment-emergent AEs are those:~with an onset date on or after the first dose of study medication,~with onset before first dose but that worsened in severity after first dose, and~for which the start of the AE in relation to the start of study medication could not be established.~The severity of AEs was classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03: June 14, 2010). AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 17.0." (NCT02260934)
Timeframe: Week 96

,
InterventionEvents (Number)
Any event leading to death≥Grade 2 leukopenia or thrombocytopeniaPremature ovarian failureMalignancyVenous thromboembolic event
Rituximab/Cyclophosphamide (RC)013003
Rituximab/Cyclophosphamide/Belimumab (RCB)016000

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Frequency of Specific Adverse Events of Interest By Participant, By Week 96

"Number of participants who experienced ≥Grade 2 specific treatment-emergent adverse events (AEs) of interest. Grade 2 or higher AEs were classified according to the listed categories of interest based on the study team's review of the AEs.~Treatment-emergent AEs are those:~with an onset date on or after the first dose of study medication,~with onset before first dose but that worsened in severity after first dose, and~for which the start of the AE in relation to the start of study medication could not be established.~The severity of AEs was classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03: June 14, 2010). AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 17.0." (NCT02260934)
Timeframe: Week 96

,
InterventionParticipants (Count of Participants)
Any event leading to death≥Grade 2 leukopenia or thrombocytopeniaPremature ovarian failureMalignancyVenous thromboembolic event
Rituximab/Cyclophosphamide (RC)06002
Rituximab/Cyclophosphamide/Belimumab (RCB)06000

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Percentage of Participants Hypocomplementemic for Complement Component C3 at Week 24, Week 48, and Week 96

"The percentage of participants who were hypocomplementemic for complement component, C3, defined as a C3 level <90 mg/dL.~Serum C3 complement is a protein which can be measured in the blood. Low blood levels of C3 are common in those with active lupus." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96

,
Interventionpercentage of participants (Number)
Week 24Week 48Week 96
Rituximab/Cyclophosphamide (RC)57.155.061.1
Rituximab/Cyclophosphamide/Belimumab (RCB)30.030.027.8

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Percentage of Participants With a Complete Response at Week 24, Week 48, and Week 96

"The percentage of participants who achieved a complete response, defined as meeting all of the following criteria:~Urine protein-to-creatinine ratio (UPCR) < 0.5, based on a 24-hour collection;~Estimated glomerular filtration rate (eGFR) ≥ 120 ml/min/1.73 m^2 calculated by the CKD-EPI formula or, if < 120 ml/min/1.73 m^2, then > 80% of eGFR at entry; and~Prednisone dose tapered to 10 mg/day and adherence to prednisone dosing provisions." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96

,
Interventionpercentage of participants (Number)
Week 24Week 48Week 96
Rituximab/Cyclophosphamide (RC)23.835.033.3
Rituximab/Cyclophosphamide/Belimumab (RCB)30.042.142.9

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Percentage of Participants With an Negative Anti-dsDNA Result at Week 24, Week 48, and Week 96

"The percentage of participants who were anti-double stranded DNA (anti-dsDNA) negative, defined as having anti-dsDNA levels <30 IU/mL.~Anti-dsDNA levels are associated with systemic lupus erythematosus disease activity." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96

,
Interventionpercentage of participants (Number)
Week 24Week 48Week 96
Rituximab/Cyclophosphamide (RC)14.320.00.0
Rituximab/Cyclophosphamide/Belimumab (RCB)15.830.027.8

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Multiple Sclerosis Functional Composite (MSFC) Z-score and Expanded Disability Status Scale (EDSS)

"MSFC score is a composite score calculated from 3 tests: 1) Timed 25-Foot walk (leg function); 2) 9-Hole Peg Test (arm function); and 3) Paced Auditory Serial Addition Test (cognitive function). The results are combined to create a single score (the MSFC Z-Score) to measure performance and change over time in subjects with MS. MSFC Z-score = {Z arm + Z leg + Z cognitive} / 3.0. A positive score indicates that, on average, an individual performed better than the reference population and a negative score indicates that, on average, an individual performed worse than the reference population.~The Expanded Disability Status Scale (EDSS) is used to quantify disability due to symptoms of MS and to track changes in disability status over time. Scores range from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). Scores are determined by performing a neurological exam and given in increments of 0.5." (NCT02296346)
Timeframe: 1 year

,
Interventionscore on a scale (Mean)
EDSS ScoreMSFC Z-Score
Corticosteroid Arm6.250.6751
ECP Arm61.1031

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Anterior Chamber Cell Grade at Week 8

Change from baseline comparison of NS2 ophthalmic drops (0.5%), NS2 (0.5%) and Pred Forte® (0.1%) ophthalmic drops, and Pred Forte® (1%) ophthalmic drops on an anterior chamber cell grade scale of 0 to 4 (0 = absent, 4 = severe). The least squares mean (standard error) was derived from analysis of covariance (ANCOVA) with baseline as a covariate and treatment group as a factor. (NCT02406209)
Timeframe: The efficacy assessment period was assessed at Week 8; baseline was Day 1.

Interventionunits on a scale (Least Squares Mean)
NS2 Ophthalmic Drops (0.5%)-0.7
NS2 (0.5%) and Pred Forte® (0.1%) Ophthalmic Drops-0.9
Pred Forte® (1%) Ophthalmic Drops-0.5

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Event-Free Survival (EFS)

EFS defined as time from the treatment start till treatment failure, relapse, or death whichever comes first. Event Free Survival will be presented by median EFS, which is the time point at which the cumulative survival drops below 50%. If there is no median survival (not reached), it means the cumulative survival was more than 50%. (NCT02464657)
Timeframe: 56 days

InterventionMonths (Median)
Ph 2 Nivolumab (3mg) + Idarubicin + CytarabineNA

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Relapse Free Survival

Relapse-free survival was defined as the time from treatment response to date of relapse or death, whichever occurred first. (NCT02464657)
Timeframe: Up to 2 years and10 Months

InterventionMonths (Median)
Ph 2 - Nivolumab (3mg) + Idarubicin + Cytarabine18.54

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Maximum Tolerated Dose (MTD) of Nivolumab

MTD is highest dose level in which <2 patients of 6 develop first cycle dose-limiting toxicity (DLT). (NCT02464657)
Timeframe: 28 days

Interventionmg/kg (Number)
Ph 1 - Nivolumab (1mg) + Idarubicin + CytarabineNA
Ph 1 - Nivolumab (3mg) + Idarubicin + Cytarabine3

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Overall Survival

Overall survival was defined as the time from the start of treatment to death or date of last follow-up. (NCT02464657)
Timeframe: Up to 2 years and 10 Months

InterventionMonths (Median)
Ph 2 Nivolumab (3mg) + Idarubicin + Cytarabine18.54

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Change From Baseline (Preoperative Exam) in Macular Thickness

Macula is the area in the retina that is responsible for the best central vision. Changes in its thickness may occur after cataract surgery due to the normal inflammatory process that occurs postoperatively but it returns to preoperative values unless there is an underlying disease. (NCT02515045)
Timeframe: Month 1.

InterventionMicrons (Mean)
TriMoxiVanc12.34
TriMoxiVanc + Ilevro10.96
Control9.84

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Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP)

Intraocular pressure refers to the pressure inside the eye. It is measured in mmHg using a device called a tonometer. The mean IOP is 15.5 mmHg. Raised IOP after cataract surgery is common and in most cases it is transient and benign. (NCT02515045)
Timeframe: Month 1.

InterventionmmHg (Mean)
TriMoxiVanc-0.5
TriMoxiVanc + Ilevro-1.03
Control-1.1

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Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness)

"Cornea is the clear part of the front of the eye. Normal corneal thickness is in average 0.540 mm. The corneal thickness is measured with a handheld device called pachymeter.~An increase in corneal thickness may indicate corneal edema (swelling of the cornea) that could be seen after ocular surgery." (NCT02515045)
Timeframe: Month 1

InterventionMicrons (Mean)
TriMoxiVanc14.44
TriMoxiVanc + Ilevro5.94
Control4.47

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Degree of Dysphagia Patients Experience (Social)

SWAL-QOL survey - Social domain Score ranges between 0 and 100 (worst-best) (NCT02539394)
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control1009585100100100100
Treatment100100100100100100100

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Patients' Bazaz Dysphagia Score - Liquid

Bazaz dysphagia scale defines dysphagia as none, mild, moderate and severe, depending on patients' symptoms with solid and liquid foods. (NCT02539394)
Timeframe: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

InterventionParticipants (Count of Participants)
Pre-operative72323489Pre-operative72323488POD172323488POD172323489POD272323488POD2723234896-4 weeks723234886-4 weeks723234893 months723234883 months723234896 months723234896 months723234881 year723234881 year72323489
NoneRare
Control47
Treatment54
Control6
Treatment2
Control20
Treatment36
Control33
Treatment20
Control17
Treatment23
Control34
Treatment31
Treatment39
Control18
Treatment17
Control39
Control11
Treatment13
Control42
Treatment41
Control9
Treatment10
Control35
Treatment40
Control10
Treatment7

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Patients' Pain Scores on the Visual Analog Scale - Right Arm Pain

Visual Analog Scale (VAS) - Right arm pain Range from 0 to 100 (best-worst) (NCT02539394)
Timeframe: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionunits on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control20237463.5
Treatment15.52.2542222.4

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Degree of Dysphagia Patients Experience (Sleep)

SWAL-QOL survey - Sleep domain Score ranges between 0 and 100 (worst-best) (NCT02539394)
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control7562.5505062.562.575
Treatment81.2556.2562.575757587.5

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Patients' Pain Scores on the Visual Analog Scale - Neck Pain

Visual Analog Scale (VAS) - Neck pain Range from 0 to 100 (best-worst) (NCT02539394)
Timeframe: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionunits on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control54.551.55120221412.25
Treatment2648.2526.514.59.566.5

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Patients' Pain Scores on the Visual Analog Scale - Left Arm Pain

Visual Analog Scale (VAS) - Left arm pain Range from 0 to 100 (best-worst) (NCT02539394)
Timeframe: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionunits on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control17.51056.455.824
Treatment195.356.452.752.51.1751

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Patients' Neck Disability

Neck Disability Index (NDI) Range from 0 to 100 (best-worst) (NCT02539394)
Timeframe: Pre-Op, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionindex (Mean)
Pre-operative4-6 weeks3 months6 months1 year
Control35.535.327.323.920.6
Treatment29.930.817.715.413.2

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Patient Reported Swallowing Difficulty Over 1 Year

"The Eating Assessment Tool (EAT-10) is used to screen for self-perceived oropharyngeal dysphagia (OD) in community-dwelling elders. A summated EAT-10 total score ranges from 0 to 40, with a score ≥ 3 indicative of OD.~Modified Eat-10 : Eat-10 questionnaire without questions 1 (My swallowing problem has caused me to lose weight) and 2 (My swallowing problem interferes with my ability to go out for meals) to be applicable during hospitalization.~Eat-10 interpretation: Score ranging from 0 to 40 (best-worst)~each question response is 0-4, 0=no problem and 4=severe problem; score is a summation of each question's response Modified EAT-10 interpretation: Score ranging from 0 to 32 (best-worst)~each question response is 0-4, 0=no problem and 4=severe problem; score is a summation of each question's response" (NCT02539394)
Timeframe: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operative Eat-10Pre-operative Eat-10 modifiedPOD1 Eat-10POD1 Eat-10 modifiedPOD2 Eat-10POD2 Eat-10 modified4-6 weeks Eat-104-6 weeks Eat-10 modified3 months Eat-103 months Eat-10 modified6 months Eat-106 months Eat-10 modified1 year Eat-101 year Eat-10 modified
Control001614161454221100
Treatment0098.58722000000

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Degree of Dysphagia Patients Experience (Mental)

SWAL-QOL survey - Mental domain Score ranges between 0 and 100 (worst-best) (NCT02539394)
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control100808595100100100
Treatment10010097.5100100100100

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Degree of Dysphagia Patients Experience (Food Selection)

SWAL-QOL survey - Food Selection domain Score ranges between 0 and 100 (worst-best) (NCT02539394)
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control1007562.5100100100100
Treatment10093.7575100100100100

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Fusion Rate

"Flex-Ex X-rays~Bony bridging on a CT scan~Obvious bony remodeling on lateral X-ray" (NCT02539394)
Timeframe: 12 Months

InterventionParticipants (Count of Participants)
Treatment25
Control23

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Adverse Event

"Adverse Event (AE) following surgical treatment.~Adverse event were classified by severity based on the AO-ISSG criteria and treatment required:~Mild: Observed, medication, consult, X-ray. Essentially any management that was quick and easy and could be done at bedside Moderate: ICU admission, re-intubation, complication that had a documented prolonged hospital stay, medical procedure (such as flexible endoscopy), re-presentation to ED Severe: Inpatient re-admission, return to OR for any reason, mortality, failed OR.~AE were also categorize as Surgery-site related or unrelated adverse event. Finally, AE were also categorize as potentially related to steroid use (example: leukocytosis, pseudoarthrosis, or wound complications)" (NCT02539394)
Timeframe: 12 month

,
InterventionParticipants (Count of Participants)
Any Adverse Event?Mild/Moderate Adverse Event?Severe Adverse Event?Adverse Event Related to Operated Site?Adverse Event Unrelated to Operated Site?Mild/Moderate Adverse Event Related to Operated Site?Mild/Moderate Adverse Event Unrelated to Operated Site?Severe Adverse Event Related to Operated Site?Severe Adverse Event Unrelated to Operated Site?Adverse Event Potentially Related to Steroid Use?Adverse Event Unrelated to Steroid use?Mild/Moderate Adverse Event Potentially Related to Steroid Use?Mild/Moderate Adverse Event Unrelated to Steroid use?Severe Adverse Event Potentially Related to Steroid Use?Severe Adverse Event Unrelated to Steroid use?
Control444233826362630114394221
Treatment4746338303730301642154112

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Degree of Dysphagia Patients Experience (Burden)

SWAL-QOL survey - Burden domain Score ranges between 0 and 100 (worst-best) (NCT02539394)
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control1005062.5100100100100
Treatment1007575100100100100

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Degree of Dysphagia Patients Experience (Communication)

SWAL-QOL survey - Communication domain Score ranges between 0 and 100 (worst-best) (NCT02539394)
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control100100100100100100100
Treatment100100100100100100100

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Degree of Dysphagia Patients Experience (Eating Desire)

SWAL-QOL survey - Eating desire domain Score ranges between 0 and 100 (worst-best) (NCT02539394)
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control10083.383.3100100100100
Treatment10087.591.7100100100100

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Degree of Dysphagia Patients Experience (Eating Duration)

SWAL-QOL survey - Eating duration domain Score ranges between 0 and 100 (worst-best) (NCT02539394)
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control100755087.5100100100
Treatment1007575100100100100

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Degree of Dysphagia Patients Experience (Fatigue)

SWAL-QOL survey - Fatigue domain Score ranges between 0 and 100 (worst-best) (NCT02539394)
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control83.3358.3358.3358.33757575
Treatment83.3358.3366.677583.3383.3391.67

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Patients' Bazaz Dysphagia Score - Solid

Bazaz dysphagia scale defines dysphagia as none, mild, moderate and severe, depending on patients' symptoms with solid and liquid foods. (NCT02539394)
Timeframe: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

InterventionParticipants (Count of Participants)
Pre-operative72323488Pre-operative72323489POD172323488POD172323489POD272323488POD2723234896-4 weeks723234896-4 weeks723234883 months723234883 months723234896 months723234886 months723234891 year723234891 year72323488
RareOccasionally (only with specific food)NoneFrequent (majority of solids)
Control44
Treatment52
Treatment17
Control8
Control21
Treatment18
Control6
Treatment15
Treatment13
Control19
Control17
Treatment27
Control18
Treatment16
Control11
Treatment11
Treatment2
Control25
Treatment34
Treatment8
Control12
Control2
Treatment0
Control30
Treatment37
Control15
Treatment10
Control5
Treatment3
Control1
Treatment1
Control29
Treatment35
Control7
Treatment6
Control9
Treatment4
Control0

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Degree of Dysphagia Patients Experience (Fear Swallow)

SWAL-QOL survey - Fear swallow domain Score ranges between 0 and 100 (worst-best) (NCT02539394)
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control10093.7587.593.75100100100
Treatment100100100100100100100

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Endoscopic Nasal Polyp Score

"0- Absence of nasal polyps~Polyps confined to the middle meatus and not beyond the inferior border of the middle turbinate~Polyps reaching below the lower border of the middle turbinate~Large polyps extending to the lower border of the inferior turbinate or medial to the middle turbinate~Large polyps extending to the lower border of the inferior turbinate or medial to the middle turbinate Nasal polyp scores. The score is determined for each nostril, and the two scores added for a total nasal polyp score. Range of 0 to 8, graded on a size system from 0 to 4 and summed from the right and left nostrils." (NCT02569437)
Timeframe: Baseline and 12 weeks

,
Interventionunits on a scale (Mean)
Baseline12 weeks
Doxycycline6.04.3
Sugar Pill6.54.9

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Subjective Symptom Composite Scoring

"A subjective symptom score will be extracted from the patient's score (on a scale of 0-5, where 0 defines no problems with the given symptom and 5 defines maximal problems ) on the SNOT-22 for each fo the following symptoms: blockage/congestion, runny nose, post-nasal discharge, facial pain/pressure, and sense of taste/smell. Range of 0 to 25, with higher score reflecting worse symptoms." (NCT02569437)
Timeframe: Baseline and 12 weeks

,
Interventionunits on a scale (Mean)
Baseline12 weeks
Doxycycline16.311.9
Sugar Pill17.113.6

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Middle Meatus Culture

Culture swab for the presence or absence of microbial growth (NCT02569437)
Timeframe: Baseline and 12 weeks

,
InterventionParticipants (Count of Participants)
Culture growth at initial visit and 12 week visitCulture growth initial visit, none at 12 weeksNo growth initial visit, but growth at 12 weeks
Doxycycline512
Sugar Pill221

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Sino-nasal Outcome Test (SNOT 22)

a validated 22 item quality of life questionnaire for patients with chronic rhinosinusitis. Range of 0 to 110, higher scores indicate worse outcome (NCT02569437)
Timeframe: Baseline and 12 weeks

,
Interventionunits on a scale (Mean)
Baseline12 weeks
Doxycycline55.243.7
Sugar Pill54.449.8

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Visual Analog Scale

The visual analog scale for overall symptoms will be used to define disease severity. Range of 0 to 10. As per the European Position Paper 2012, mild, moderate, and severe disease will be defined as 0 to and including 3, > 3 to and including 7, and > 7 to and including 10, respectively. (NCT02569437)
Timeframe: Baseline and 12 weeks

,
Interventionunits on a scale (Mean)
Baseline12 weeks
Doxycycline8.45.2
Sugar Pill8.14.5

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The Knee Osteoarthritis Outcome Score (KOOS) Pain Subscale

The KOOS holds 42 items in five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. (NCT02576249)
Timeframe: 3 months after the injection

Interventionunits on a scale (Mean)
Ropivacaine and Methylprednisolone63.1
Saline and Methylprednisolone67.2

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Pain Scale Score

Pain was measured by a Visual Analog Scale (VAS) marked from 0 (no pain) to 10 (unbearable pain) at rest and with activity. It was collected at baseline (pre-injection), immediately post-injection on the day of surgery, and at 2 weeks and 3 months. (NCT02576249)
Timeframe: Pre-injection, immediately post-injection, 2 weeks, 3 months

,
Interventionunits on a scale (Mean)
Pre-injection ActivityPre-injection RestImmediately Post-injection ActivityImmediately Post-injection Rest2 Weeks Activity2 Weeks Rest3 Months Activity3 Months Rest
Ropivacaine and Methylprednisolone6.42.41.91.23.61.73.92.6
Saline and Methylprednisolone5.842.41.43.62.74.62.8

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Tegner Activity Level Scale

"The Tegner activity level scale is a scale that aims to provide a standardized method of grading work and sporting activities. The Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The patient is asked to select the level of participation that best describes their current level of activity and that before injury.~A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports. A score >6 can only be achieved if the person participates in recreational or competitive sport." (NCT02576249)
Timeframe: baseline (pre-injection), 2 weeks, 3 months

,
Interventionunits on a scale (Mean)
baseline (pre-injection)2 weeks3 months
Ropivacaine and Methylprednisolone3.54.33.5
Saline and Methylprednisolone3.03.23

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Symptom Severity Score

Change in symptom severity score from baseline to 5 to 7 years. Score range 1 (no symptoms) to 5 (most severe symptoms). (NCT02652390)
Timeframe: 5-7 years

Interventionscore on a scale (Mean)
80-mg Mrthylprednisolone and no Surgery1.34
Surgery After Methylprednisolone or Placebo1.53

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Satisfaction Score

Visual analog scale about treatment satisfaction, score 0 (worst) to 100 (best). (NCT02652390)
Timeframe: 5-7 years

Interventionscore on a scale (Mean)
Methylprednisolone 80 mg77.5
Methylprednisolone 40 mg71.4
Placebo68.4

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Palmar Pain Score

Score for pain in the proximal palm and related activity limitations, range 0 (worst) to 100 (best). (NCT02652390)
Timeframe: 5-7 years

Interventionscore on a scale (Mean)
Methylprednisolone 80 mg86.4
Methylprednisolone 40 mg84.6
Placebo83.0

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Number of Patients Who Have Had Carpal Tunnel Release Surgery on the Study Hand

Number of patients who have had carpal tunnel release surgery on the study hand. (NCT02652390)
Timeframe: 5 to 7 years

InterventionParticipants (Count of Participants)
Methylprednisolone 80 mg31
Methylprednisolone 40 mg34
Placebo36

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Bodily Pain Score

Score for the 2-item bodily pain scale, range 0 (worst) to 100 (best). (NCT02652390)
Timeframe: 5-7 years

Interventionscore on a scale (Mean)
Methylprednisolone 80 mg81.4
Methylprednisolone 40 mg79.9
Placebo78.2

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11-item Disabilities of the Arm, Shoulder and Hand (DASH) Score

Score for the 11-item DASH scale, a measure of activity limitations related to the upper extremity. Score range 0 (best) to 100 (worst) (NCT02652390)
Timeframe: 5-7 years

Interventionscore on a scale (Mean)
Methylprednisolone 80 mg13.1
Methylprednisolone 40 mg16.9
Placebo19.3

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Organ Failure-free Days.

Number of organ failure-free days during days 1 through 60 postrandomization. Organ failure free=corresponding Sequential Organ Failure Assessment Subscore <3; each subscore can have the following values: 0, 1, 2, 3, and 4; increasing values indicate worsening organ failure. (NCT02790788)
Timeframe: Days 1 to 60 postrandomization.

InterventionNumber of Days without Organ Failure (Median)
Steroids Group0
Control Group0

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Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring.

Results on postresuscitation, mean arterial blood pressure (mmHg) are provided for the fourth, pre-specified time point of measurement, i.e. at 48 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: 48 hours after ROSC.

InterventionmmHg (Mean)
Steroids Group80.2
Control Group84.2

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Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port.

Results on postresuscitation central venous oxygen saturation (%) are provided for the fourth, pre-specified time point of measurement, i.e., at 48 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: 48 hours after ROSC.

InterventionPercent Hemoglobin Concentration (Mean)
Steroids Group73.3
Control Group70.5

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Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port.

Results on postresuscitation central venous oxygen saturation (%) are provided for the fifth, pre-specified time point of measurement, i.e., at 72 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: 72 hours after ROSC.

InterventionPercent Hemoglobin Saturation (Mean)
Steroids Group72.5
Control Group70.4

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Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port (as Feasible).

Results on postresuscitation central venous oxygen saturation (%) are provided for the second, pre-specified time point of measurement, i.e., at 4 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: 4 hours after ROSC.

InterventionPercent Hemoglobin Concentration (Mean)
Steroids Group67.4
Control Group56.8

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Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.

Results are provided for CO at 72 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: 72 hours after ROSC.

InterventionL/min (Mean)
Steroids Group5.8
Control Group5.6

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Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.

Results are provided for CO at 48 hours after ROSC (NCT02790788)
Timeframe: Time points of measurement: 48 hours after ROSC.

InterventionL/min (Mean)
Steroids Group5.8
Control Group5.7

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Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.

Results are provided for CO at 24 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: 24 hours after ROSC.

InterventionL/min (Mean)
Steroids Group5.6
Control Group5.4

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Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.

RESULTS ARE PROVIDED FOR CARDIAC OUTPUT (CO) AT 4 HOURS AFTER ROSC. (NCT02790788)
Timeframe: Time points of measurement: 4 hours after ROSC.

InterventionL/min (Mean)
Steroids Group4.9
Control Group5.0

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Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring.

Results on postresuscitation, mean arterial blood pressure (mmHg) are provided for the third, pre-specified time point of measurement, i.e. at 24 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: 24 hours after ROSC.

InterventionmmHg (Mean)
Steroids Group79.9
Control Group81.9

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Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring (as Feasible).

Results on early postresuscitation, mean arterial blood pressure (mmHg) are provided for the second, pre-specified time point of measurement, i.e. at 4 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: 4 hours after ROSC.

InterventionmmHg (Mean)
Steroids Group83.9
Control Group78.9

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Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring (as Feasible).

Results on early postresuscitation, mean arterial blood pressure (mmHg) are provided for the first, pre-specified time point of measurement, i.e. at 20 min after the return of spontaneous circulation (ROSC). (NCT02790788)
Timeframe: Time point of measurement: 20 min after the return of spontaneous circulation (ROSC).

InterventionmmHg (Mean)
Steroids Group78.4
Control Group75.1

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Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port.

Results on postresuscitation central venous oxygen saturation (%) are provided for the third, pre-specified time point of measurement, i.e., at 24 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: 24 hours after ROSC.

InterventionPercent Hemoglobin Concentration (Mean)
Steroids Group71.1
Control Group70.1

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Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring.

Results on postresuscitation, mean arterial blood pressure (mmHg) are provided for the fifth, pre-specified time point of measurement, i.e. at 72 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: 72 hours after ROSC.

InterventionmmHg (Mean)
Steroids Group85.2
Control Group84.7

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Left and Right Ventricular Diastolic Area (cm^2) by Echocardiography.

Results are provided on left ventricular end-diastolic area (LVEDA) and right ventricular diastolic area (RVEDA) by echocardiography within 12 hours and 72 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: Within the first 12 hours and at 72 hours postresuscitation.

,
Interventioncm^2 (Mean)
LVEDA within 12 hours after ROSCRVEDA within 12 hours after ROSCLVEDA at 72 hours after ROSCRVEDA at 72 hours after ROSC
Control Group22.813.018.512.6
Steroids Group23.112.123.114.5

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Eccentricity Index by Echocardiography.

"Eccentricity index (ECCI) is defined as the ratio of the left ventricular (LV) longitudinal (or anteroposterior) diameter to the LV transverse (or septo-lateral) diameter, measured at end diastole and end systole in a short-axis view. Pertinent results are provided for a first determination within 12 hours after ROSC and a second determination at 72 hours after ROSC." (NCT02790788)
Timeframe: Time points of measurement: Within the first 12 hours and at 72 hours postresuscitation.

,
InterventionECCENTRICITY INDEX (Mean)
End-diastolic ECCI within 12 hours after ROSCEnd-systolic ECCI within 12 hours after ROSCEnd-diastolic ECCI at 72 hours after ROSCEnd-systolic ECCI at 72 hours after ROSC
Control Group1.31.31.31.3
Steroids Group1.21.31.21.2

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Early Postresuscitation Inflammatory Response as Assessed by Serum Cytokine Levels (pg/mL).

Logarithm (base 10)-transformed serum levels of tumor necrosis factor alpha (TNFa), interleukin (IL)-1 beta, IL-6, IL-8, and IL-10; blood samples were obtained by venipuncture. (NCT02790788)
Timeframe: Time points of measurement: 4, 24, 48, and 72 hours postresuscitation.

,
InterventionLog(10) transformed values of pg/mL (Mean)
IL-6 at 4 hours after ROSCTNFα at 4 hours after ROSCIL-1β at 4 hours after ROSCIL-8 at 4 hours after ROSCIL-10 at 4 hours after ROSCIL-6 at 24 hours after ROSCTNFα at 24 hours after ROSCIL-1β at 24 hours after ROSCIL-8 at 24 hours after ROSCIL-10 at 24 hours after ROSCIL-6 at 48 hours after ROSCTNFα at 48 hours after ROSCIL-1β at 48 hours after ROSCIL-8 at 48 hours after ROSCIL-10 at 48 hours after ROSCIL-6 at 72 hours after ROSCTNFα at 72 hours after ROSCIL-1β at 72 hours after ROSCIL-8 at 72 hours after ROSCIL-10 at 72 hours after ROSC
Control Group2.222.032.032.431.761.992.002.092.291.541.911.962.032.171.531.901.962.042.191.45
Steroids Group2.191.972.072.391.762.062.022.062.271.691.871.992.092.151.561.932.002.052.151.66

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Core Body Temperature in Degrees Celcius.

Results are provided for core body temperature averaged over the following time intervals after ROSC: 1) 0-6 hours; 2) 6-12 hours; 3) 12-18 hours; 4) 18-24 hours; 5) 24-30 hours; 6) 30-36 hours; 7) 36-42 hours; and 42-48 hours. (NCT02790788)
Timeframe: Time points of measurement: Hourly from intensive care admission to 48 hours postresuscitation.

,
InterventionDegrees Celcius (Mean)
Temperature averaged over 0-6 hours after ROSCTemperature averaged over 6-12 hours after ROSCTemperature averaged over 12-18 hours after ROSCTemperature averaged over 18-24 hours after ROSCTemperature averaged over 24-30 hours after ROSCTemperature averaged over 30-36 hours after ROSCTemperature averaged over 36-42 hours after ROSCTemperature averaged over 42-48 hours after ROSC
Control Group35.636.636.536.336.236.236.236.3
Steroids Group36.536.336.036.136.136.036.136.2

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Cerebral Blood Flow Index by Near Infrared Spectroscopy With Indocyanine Green.

Results are reported for 2 pairs of cerebral blood flow index (CBFI) measurements performed each time at a lower and a higher level of mean arterial pressure (MAP) at the following time points: 1) at 4 hours after ROSC and 2) at 72 hours after ROSC (NCT02790788)
Timeframe: Time points of measurement: 4 and 72 hours postresuscitation.

,
InterventionnM/s (Mean)
CBFI 4 HOURS POST-ROSC MEAN MAP=75.5 MMHGCBFI 4 HOURS POST-ROSC MEAN MAP=96.0 MMHGCBFI 72 HOURS POST-ROSC MEAN MAP=75.5 MMHGCBFI 72 HOURS POST-ROSC MEAN MAP= 97.0 MMHG
Control Group3.33.53.43.8
Steroids Group4.04.24.34.9

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Survival to Hospital Discharge With Favorable Functional Outcome.

Survival to hospital discharge with a Cerebral Performance Category (CPC) Score of 1 or 2. The CPC Score ranges can have the following values: 1, 2, 3, 4, and 5; lower Scores correspond to better outcomes, whereas higher Scores reflect worsening outcomes, e.g. a Score of 4 means Coma or Vegetative state, and a Score of 5 means Brain Death. (NCT02790788)
Timeframe: Up to 180 days postrandomization.

InterventionParticipants (Count of Participants)
Steroids Group2
Control Group5

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Steroid-associated Complications.

Episodes of 1) Hyperglycemia (defined as Blood Glucose >200 mg/dL), 2) Hypernatremia (defined as blood gas analysis-derived sodium ion concentration >150 mEq/L), and 3) Infections (defined as any microbiologically documented, intensive care unit-acquired, or hospital-acquired infection). (NCT02790788)
Timeframe: Up to 180 days postrandomization.

,
InterventionNumber of Episodes per Patient (Median)
No. of Episodes of HyperglycemiaNo. of Episodes of HypernatremiaNo. of Episodes of Infections
Control Group000
Steroids Group000

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Left and Right Ventricular Ejection Fraction (%) by Echocardiography.

Results are provided on left ventricular ejection fraction (LVEF) and right ventricular ejection fraction (RVEF) within 12 hours and 72 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: Within the first 12 hours and at 72 hours postresuscitation.

,
InterventionPercentage (Mean)
LVEF within 12 hours after ROSCRVEF within 12 hours after ROSCLVEF at 72 hours after ROSCRVEF at 72 hours after ROSC
Control Group45.942.75044.7
Steroids Group42.341.74542.8

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Number of Participants Sampled for RNA-seq Differential Expression Analysis (Biological Replicates)

Number of participants (biological replicates) that were successfully sampled for RNA-seq differential gene expression analysis in glucocorticoid-treated immune cells. The analysis employed a cutoff value of < 5% false-discovery rate (FDR) to select the transcripts that were considered differentially expressed at each time point. The resulting gene lists were contrasted to determine which genes were uniquely differentially expressed in different cell types. (NCT02798523)
Timeframe: Up to 2 or 4 hours post infusion depending on group

InterventionParticipants (Count of Participants)
Up to 2 Hours Post Infusion5
Up to 4 Hours Post Infusion20

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Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 5 of First Course of Azacitidine

Will calculate the percentage of CpG site methylation for all patients after the first course of azacitidine. Mean and standard deviation will be reported. (NCT02828358)
Timeframe: Week 6, Day 5 (Following the induction phase (35 days), the first course of Azacitidine began around Week 6 of therapy)

InterventionPercentage of CpG methylation (Mean)
KMT2A-Rearranged75.54

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Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 1 Prior to First Course of Azacitidine

Will calculate the percentage of CpG site methylation for all patients before the first course of azacitidine. Mean and standard deviation will be reported. (NCT02828358)
Timeframe: Week 6, Day 1 (Following the induction phase (35 days), the first course of Azacitidine began around Week 6 of therapy)

InterventionPercentage of CpG methylation (Mean)
KMT2A-Rearranged78.17

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Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 1 Prior to Second Course of Azacitidine

Will calculate the percentage of CpG site methylation for all patients before the second course of azacitidine. Mean and standard deviation will be reported. (NCT02828358)
Timeframe: Week 13, Day 1 (Following induction phase (5 weeks), the first course of Azacitidine (1 week), and consolidation (6 weeks), the second course of Azacitidine began around Week 13 of therapy)

InterventionPercentage of CpG methylation (Mean)
KMT2A-Rearranged76.5

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Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 5 of Second Course of Azacitidine

Will calculate the percentage of CpG site methylation for all patients after the second course of azacitidine. Mean and standard deviation will be reported. (NCT02828358)
Timeframe: Week 13, Day 5 (Following induction phase (5 weeks), the first course of Azacitidine (1 week), and consolidation (6 weeks), the second course of Azacitidine began around Week 13 of therapy)

InterventionPercentage of CpG methylation (Mean)
KMT2A-Rearranged74.52

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Tolerability of Azacitidine in Combination With Interfant-06 Standard Chemotherapy in Evaluable Infant Patients With Newly Diagnosed ALL With KMT2A Gene Rearrangement (KMT2A-R). KMT2A Gene Rearrangement (KMT2A-R)

Proportion of KMT2A-Rearranged patients treated with azacitidine with Dose Limiting Toxicities (DLTs) from the first course of azacitidine administration up to fourth course of azacitidine administration. (NCT02828358)
Timeframe: 6 months

Interventionpercentage of participants (Number)
KMT2A-Rearranged6.45

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Headache Days as Self-reported by Participants

At the seven day follow-up, participants will be asked by phone how many days they experienced headaches since being discharged. (NCT02847494)
Timeframe: 7 days after discharge from emergency department

Interventiondays (Mean)
Control3.0
Experimental3.3

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Medication Preference as Assessed by Self-report

"Participants will be asked, by phone, if they would want the same medication during a subsequent visit to the emergency department. Reported values indicate participants who responded yes." (NCT02847494)
Timeframe: 7 days after discharge from emergency department

InterventionParticipants (Count of Participants)
Control76
Experimental75

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Number of Participants With Sustained Headache Freedom

Sustained headache freedom is defined as achieving a headache intensity = none within two hours of treatment and maintaining this level, without requiring additional headache medication, for 7 days following discharge from the Emergency Department. Participants will be asked by phone how number of days they experienced headaches during the week after discharge from the emergency department. Reported values are participants who experienced no headaches at all during the 7 days immediately following discharge. (NCT02847494)
Timeframe: 7 days after discharge from emergency department

InterventionParticipants (Count of Participants)
Control10
Experimental6

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Overall Response Rate (ORR)

Defined as the percentage of participants demonstrating a CR, VGPR, or PR. (NCT02953678)
Timeframe: From baseline to days 14, 56, and 100

Interventionpercentage of participants (Number)
Day 14Day 56Day 100
Ruxolitinib in Combination With Corticosteroids62.036.632.4

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Number of Participants With Treatment-emergent Adverse Events (TEAES), Serious TEAEs, And Grade 3 or Higher TEAEs

AE was any unfavorable and unintended sign, symptom, or disease temporally associated with use of medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. Serious AE was any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization. TEAE was an AE that was reported for the first time, or worsening of a pre-existing event after the first dose of study drug (until 30 days after the last dose of study drug). Severity of AEs was described and graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03). Grade 3 and above would constitute a severe, life-threatening, or death event. (NCT02953678)
Timeframe: From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)

InterventionParticipants (Count of Participants)
TEAEsSerious TEAEsGrade 3 or Higher TEAEs
Ruxolitinib in Combination With Corticosteroids715969

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Relapse Rate

Defined as the percentage of participants whose underlying malignancy relapsed. (NCT02953678)
Timeframe: From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months)

Interventionpercentage of participants (Number)
Ruxolitinib in Combination With Corticosteroids7.0

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Percentage of Participants With Three-month DOR

Defined as the time from first response until GVHD progression or death. DOR was assessed when all participants who were on the study completed the Day 84 visit. (NCT02953678)
Timeframe: From Baseline up to 3 months

Interventionpercentage of participants (Number)
Ruxolitinib in Combination With Corticosteroids84.5

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Overall Survival (OS)

Defined as the time from study enrollment (first day of ruxolitinib treatment) to death due to any cause. (NCT02953678)
Timeframe: From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months)

Interventiondays (Median)
Ruxolitinib in Combination With Corticosteroids232.0

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Failure-free Survival (FFS)

Defined as the time from first dose of ruxolitinib to the earliest date that a participant died, had a relapse/progression of the underlying malignancy, required additional therapy for aGVHD, or demonstrated signs or symptoms of chronic graft-versus-host disease (cGVHD). (NCT02953678)
Timeframe: From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months)

Interventiondays (Median)
Ruxolitinib in Combination With Corticosteroids85.0

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Overall Response Rate (ORR) at Day 28

Defined as the percentage of participants demonstrating a complete response (CR), very good partial response (VGPR), or partial response (PR). (NCT02953678)
Timeframe: From baseline to Day 28

InterventionParticipants (Count of Participants)
Responders - CRResponders - VGPRResponders - PR
Ruxolitinib in Combination With Corticosteroids19713

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Percentage of Participants With Six-month Duration of Response (DOR)

Defined as the time from first response until graft-versus-host disease (GVHD) progression or death. DOR was assessed when all participants who were on the study completed the Day 180 visit. (NCT02953678)
Timeframe: From Baseline up to 6 months

Interventionpercentage of participants (Number)
Ruxolitinib in Combination With Corticosteroids68.2

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Nonrelapse Mortality (NRM)

Defined as the proportion of subjects who died due to causes other than malignancy relapse. (NCT02953678)
Timeframe: From baseline to Months 6, 9, 12, and 24

Interventionpercentage of participants (Number)
6 months9 months12 months24 months
Ruxolitinib in Combination With Corticosteroids44.448.252.964.8

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Systemic Clearance at Steady State (CLss) of GLASSIA

CLss of GLASSIA was reported. (NCT02956122)
Timeframe: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours

InterventionDeciliters per hour (dL/h) (Number)
GLASSIA: Day 13: 30 mg/kg0.297
GLASSIA: Day 22: 120 mg/kg0.286
GLASSIA: Day 50: 120 mg/kg0.260

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"Area Under the Plasma Concentration Curve From Time Zero to Time t AUC(0-t) of GLASSIA"

AUC(0-t) of GLASSIA was reported. (NCT02956122)
Timeframe: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours

Interventionh*mg/dL (Number)
GLASSIA: Day 1: 90 mg/kg16300
GLASSIA: Day 13: 30 mg/kg11000
GLASSIA: Day 22: 120 mg/kg40400
GLASSIA: Day 50: 120 mg/kg33400

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Percentage of Participants Achieving Overall Response at Day 56

Overall response was defined as graft-versus-host disease (GvHD) complete response (CR) + partial response (PR), defined as: - GvHD CR was complete resolution of all signs and symptoms of acute GvHD in all organs without intervening salvage - GvHD PR was improvement of 1 stage in 1 or more organs involved in GvHD without progression in other organs. (NCT02956122)
Timeframe: Day 56

InterventionPercentage of participants (Number)
GLASSIA100

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Failure-free Survival - Percentage of Participants With an Event

Failure-free survival was defined as the absence of all of the following criteria: Need for second-line treatment for acute GvHD, Non-relapse mortality (death during continuous complete remission) and recurrent malignancy. (NCT02956122)
Timeframe: Days 100 and 180

InterventionPercentage of participants (Number)
Day 100Day 180
GLASSIA100100

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Graft-versus-host Disease (GvHD)-Free Survival - Percentage of Participants With an Event

GVHD-free survival was defined as being alive without previous onset of acute GVHD or chronic GVHD requiring immunosuppressive therapy. (NCT02956122)
Timeframe: Days 28, 56, 100, 180 and 365

InterventionPercentage of participants (Number)
Day 28Day 56Day 100Day 180Day 365
GLASSIA100100100100100

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Graft-versus-host Disease (GvHD)-Related Mortality - Percentage of Participants With an Event

Graft-versus-host disease (GvHD)-related mortality was determined by the investigator (any deaths considered related to GvHD). (NCT02956122)
Timeframe: Days 28, 56, 100 and 180

InterventionPercentage of participants (Number)
Day 28Day 56Day 100Day 180
GLASSIA0000

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Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180

Grading of GvHD was performed by the investigator according to the modified International Bone Marrow Transplant Registry (IBMTR) grading system which classifies the degree of involvement of each organ system by stage on a scale of 0 to 4. The degree of skin involvement was staged depending upon degree and severity of the lesions: Stage 1: Maculopapular rash over less than (<) 25% of body area, Stage 2: Maculopapular rash over 25 to 50% of body area, Stage 3: Generalized erythroderma, Stage 4: Generalized erythroderma with bullous formation. Degree of GI involvement was staged based on severity of diarrhoea: Stage 1: 500 to 1000 mL/day,Stage 2: 1000 to 1500 mL/day, Stage 3: 1500 to 2000 mL/day, Stage 4: greater than (>) 2000 mL/day OR pain OR ileus. Degree of liver involvement was staged based upon serum total bilirubin level as follows: Stage 1: 2 to 3 mg/dL, Stage 2: 3 to 6 mg/dL, Stage 3: 6 to 15 mg/dL, Stage 4: >15 mg/dL. (NCT02956122)
Timeframe: Days 28, 56 and 180

InterventionParticipants (Count of Participants)
Day 28: Degree of skin Involvement72260019Day 28: Degree of GI Involvement72260019Day 28: Degree of liver Involvement72260019Day 56: Degree of skin Involvement72260019Day 56: Degree of GI Involvement72260019Day 56: Degree of liver Involvement72260019Day 180: Degree of skin Involvement72260019Day 180: Degree of GI Involvement72260019Day 180: Degree of liver Involvement72260019
Stage 1Stage 3Stage 4Stage 0Stage 2
GLASSIA1
GLASSIA0

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Overall Survival (OS) - Percentage of Participants With an Event

OS was defined as the time from the date of randomization to the date of death due to any cause. (NCT02956122)
Timeframe: Days 100, 180 and 365

InterventionPercentage of participants (Number)
Day 100Day 180Day 365
GLASSIANANANA

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Incidence of Chronic Graft-versus-host Disease (GvHD)

Incidence of chronic GvHD at Days 180 and 365 was reported. (NCT02956122)
Timeframe: Days 180 and 365

InterventionParticipants (Number)
Day 180Day 365
GLASSIA00

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Infection-related Mortality - Percentage of Participants With an Event

Infection-related mortality was determined by the investigator (any deaths considered related to infection [including infections related to hematopoietic stem cell transplant {HSCT}]). (NCT02956122)
Timeframe: Days 28, 56, 100 and 180

InterventionPercentage of participants (Number)
Day 28Day 56Day 100Day180
GLASSIA0000

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All-cause Mortality - Percentage of Participants With an Event

All-cause mortality was defined as the time from HSCT to death due to any cause. (NCT02956122)
Timeframe: Days 28, 56, 100 and 180

InterventionPercentage of participants (Number)
Day 28Day 56Day 100Day180
GLASSIA0000

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Percentage of Participants Achieving Overall Response (OR) At Day 28

OR was defined as graft-versus-host disease (GvHD) complete response (CR) + partial response (PR), defined as: - GvHD CR was complete resolution of all signs and symptoms of acute GvHD in all organs without intervening salvage and GvHD PR was improvement of 1 stage in 1 or more organs involved in GvHD without progression in other organs. (NCT02956122)
Timeframe: Day 28

InterventionPercentage of participants (Number)
GLASSIA100

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Number of Participants With Recurrence of Primary Malignancies

Incidence of recurrence of primary malignancies was reported. (NCT02956122)
Timeframe: Baseline up to Day 365

InterventionParticipants (Count of Participants)
GLASSIA0

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Number of Participants With Clinically Significant Changes in Vital Signs

Vital signs included body temperature, respiratory rate, pulse rate and systolic and diastolic blood pressure. (NCT02956122)
Timeframe: Baseline up to Day 56

InterventionParticipants (Count of Participants)
GLASSIA0

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Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments

Clinical laboratory assessments such as hematology, clinical chemistry, lipid and coagulation panels and urinalysis were performed. (NCT02956122)
Timeframe: Baseline up to Day 56

InterventionParticipants (Count of Participants)
GLASSIA0

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Maximum Observed Plasma Concentration (Cmax) of GLASSIA

Cmax of GLASSIA was reported. (NCT02956122)
Timeframe: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours

InterventionMilligrams per deciliter (mg/dl) (Number)
GLASSIA: Day 1: 90 mg/kg339
GLASSIA: Day 13: 30 mg/kg262
GLASSIA: Day 22: 120 mg/kg390
GLASSIA: Day 50: 120 mg/kg409

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Area Under the Plasma Concentration Curve (AUC0-inf) From Time Zero to Infinity

AUC of GLASSIA was reported. (NCT02956122)
Timeframe: Day 1: through 48 hours; Day 13: through 48 hours; Day 22 and Day 50: through approximately 168 hours

InterventionHour*milligrams per deciliter (h*mg/dL) (Number)
GLASSIA: Day 1: 90 mg/kg61500
GLASSIA: Day 13: 30 mg/kg43500
GLASSIA: Day 22: 120 mg/kg126000
GLASSIA: Day 50: 120 mg/kg117000

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Apparent Volume of Distribution at Steady State (Vss) of GLASSIA

Vss of GLASSIA was reported. (NCT02956122)
Timeframe: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours

InterventionDeciliter (dL) (Number)
GLASSIA: Day 13: 30 mg/kg50.9
GLASSIA: Day 22: 120 mg/kg123
GLASSIA: Day 50: 120 mg/kg91.1

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Apparent Terminal Half-life (t1/2) of GLASSIA

Apparent terminal half-life (hour), determined as ln2/lambda-z. lambda-z is the apparent terminal rate constant (one per hour), determined by linear regression of the terminal points of the log-linear concentration-time curve. Visual assessment will be used to identify the terminal linear phase of the concentration-time profile. A minimum of 3 data points will be used for determination. t1/2 of GLASSIA was reported. (NCT02956122)
Timeframe: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours

InterventionHour (h) (Number)
GLASSIA: Day 1: 90 mg/kg152
GLASSIA: Day 13: 30 mg/kg117
GLASSIA: Day 22: 120 mg/kg317
GLASSIA: Day 50: 120 mg/kg247

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Percentage of Participants Achieving Gastrointestinal (GI) Response at Day 28

GI response was defined as complete response (CR) + partial response (PR), defined as: - GI CR was able to eat; not requiring parenteral nutrition, and passing primarily formed stools - GI PR was decrease in need for parenteral nutrition to less than or equal to (<=) 50% of required calories; and reduction of stool volume by greater than or equal to (>=) 50%, without ileus. (NCT02956122)
Timeframe: Day 28

InterventionPercentage of participants (Number)
GLASSIA100

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Percentage of Subjects With Prostate Specific Antigen - 50 Response

A decrease of ≥50% reduction from baseline of the study CHL-AA-201 (NCT02962284)
Timeframe: 360 days

Interventionpercentage of number of subjects (Number)
Preceding Treatment - Yonsa60.0
Preceding Treatment - Zytiga55.6

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Testosterone Levels

Change in serum testosterone levels from baseline (NCT02962284)
Timeframe: Baseline and 360 days

Interventionng/dL (Mean)
Preceding Treatment - Yonsa-6.24
Preceding Treatment - Zytiga-5.87

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Testosterone Complete Suppression

Proportion of subjects with complete suppression of testosterone levels (NCT02962284)
Timeframe: 360 days

Interventionpercentage of subjects (Number)
Preceding Treatment - Yonsa100
Preceding Treatment - Zytiga87.5

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Prostate Specific Antigen Levels

Change in serum testosterone levels after one year of treatment against baseline (NCT02962284)
Timeframe: One year

Interventionng/dL (Mean)
Preceding Treatment - Yonsa-60.12
Preceding Treatment - Zytiga-112.76

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Number of Subjects With Adverse Events

Adverse events (NCT02962284)
Timeframe: one year

InterventionParticipants (Number)
Preceding Treatment - Yonsa8
Preceding Treatment - Zytiga9

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Proportion of Subjects With Disease Progression

Number of participants who had disease progression (NCT02962284)
Timeframe: one year

InterventionParticipants (Count of Participants)
Preceding Treatment - Yonsa1
Preceding Treatment - Zytiga3

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Uncorrected Visual Acuity

Best uncorrected visual acuity will be measured at 3 months (NCT03123614)
Timeframe: 3 months

InterventionlogMAR (Mean)
Loteprednol Etabonate 0.5% Oph Gel-0.078
Prednisolone Acetate 1% Oph Susp-0.075

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Change in Intraocular Pressure (IOP) From Baseline Through Month 3

Intraocular pressure will be measured by applanation tonometry (NCT03123614)
Timeframe: Baseline, 1 week post-op, 1 month post-op, 2 months post-op, 3 months post-op

,
InterventionmmHg (Mean)
Baseline intraocular pressure (IOP)IOP 1 week postopIOP 1 month postopIOP 2 months postopIOP 3 months postop
Loteprednol Etabonate 0.5% Oph Gel14.3813.6714.1513.3613.15
Prednisolone Acetate 1% Oph Susp14.3013.2814.6013.1612.22

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Best Corrected Visual Acuity at 3 Months

Best uncorrected visual acuity will be measured at 3 months (NCT03123614)
Timeframe: 3 months

InterventionlogMAR (Mean)
Loteprednol Etabonate 0.5% Oph Gel-0.120
Prednisolone Acetate 1% Oph Susp-0.114

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Number of Eyes With Corneal Haze

As determined by slit lamp examination (NCT03123614)
Timeframe: 12 months

InterventionEyes (Count of Units)
Loteprednol Etabonate 0.5% Oph Gel3
Prednisolone Acetate 1% Oph Susp7

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Cmax of Itacitinib When Administered in Combination With Corticosteroids

Defined as maximum observed plasma concentration. (NCT03139604)
Timeframe: Protocol-defined timepoints up to Day 28

InterventionnM (Mean)
Itacitinib Plus Corticosteroids796

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Cmin of Itacitinib When Administered in Combination With Corticosteroids

Defined as minimum observed plasma concentration. (NCT03139604)
Timeframe: Protocol-defined timepoints up to Day 28

InterventionnM (Mean)
Itacitinib Plus Corticosteroids72.5

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Duration of Response

Defined as the interval from first response until GVHD progression or death. (NCT03139604)
Timeframe: Baseline through 30-35 days after end of treatment, total particpation expected to average 24 months

Interventiondays (Median)
Itacitinib Plus Corticosteroids587
Placebo Plus CorticosteroidsNA

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Failure-free Survival

Defined as the proportion of subjects who are still alive, have not relapsed, have not required additional therapy for aGVHD, and have not demonstrated signs or symptoms of chronic graft-versus-host disease (cGVHD) (NCT03139604)
Timeframe: 6 months from randomization

Interventionproportion of participants (Number)
Itacitinib Plus Corticosteroids44.29
Placebo Plus Corticosteroids40.00

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Incidence Rate of Secondary Graft Failure

Defined as > 95% recipient cells any time after engraftment with no signs of relapse, OR retransplantation because of secondary neutropenia (< 0.5 × 109/L) and/or thrombocytopenia (< 20 × 109/L) within 2 months of transplantion (NCT03139604)
Timeframe: Randomization through end of Study, study duration expected to average 24 months

Interventionparticipants (Number)
Itacitinib Plus Corticosteroids2
Placebo Plus Corticosteroids0

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Number of Treatment-emergent Adverse Events With INCB39110

Adverse events reported for the first time or worsening of a pre-existing event after the first dose of study treatment (NCT03139604)
Timeframe: 30-35 days after end of treatment, approximately 24 months

Interventionparticipants (Number)
Itacitinib Plus Corticosteroids208
Placebo Plus Corticosteroids214

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Incidence Rate of aGVHD Flares

(NCT03139604)
Timeframe: up to day 100

Interventionparticipants (Number)
Itacitinib Plus Corticosteroids42
Placebo Plus Corticosteroids48

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Overall Response Rate Based on Center for International Blood and Marrow Transplant Research (CIBMTR) Response Index

Defined as the percentage of participants demonstrating a complete response (CR), very good partial response (VGPR), or partial response (PR). (NCT03139604)
Timeframe: Day 28

InterventionPercentage of Participants (Number)
Itacitinib Plus Corticosteroids74.0
Placebo Plus Corticosteroids66.4

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Overall Survival (OS)

Defined as the interval from study enrollment to death due to any cause. (NCT03139604)
Timeframe: End of Study up to approximately 24 months

Interventiondays (Median)
Itacitinib Plus Corticosteroids365
Placebo Plus Corticosteroids348.5

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Relapse Rate of Malignant and Nonmalignant Hematologic Disease

Defined as the proportion of subjects whose underlying hematologic disease relapses (NCT03139604)
Timeframe: Randomization through end of Study, study duration expected to average 24 months

Interventionpercentage (Number)
Itacitinib Plus Corticosteroids12.4
Placebo Plus Corticosteroids11.4

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Time to Response

Defined as the interval from treatment initiation to first response (NCT03139604)
Timeframe: End of Study, total particpation expected to average 24 months

Interventiondays (Mean)
Itacitinib Plus Corticosteroids9.9
Placebo Plus Corticosteroids10.1

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Tmax of Itacitinib When Administered in Combination With Corticosteroids

Defined as time to maximum plasma concentration. (NCT03139604)
Timeframe: Protocol-defined timepoints up to Day 28

Interventionhrs (Median)
Itacitinib Plus Corticosteroids2.1

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Incidence Rate of cGVHD

(NCT03139604)
Timeframe: Days 180 and 365

,
Interventionparticipants (Number)
Day 180Day 365
Itacitinib Plus Corticosteroids2543
Placebo Plus Corticosteroids3658

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Nonrelapse Mortality

Defined as the percentage of participants who died due to causes other than malignancy relapse. (NCT03139604)
Timeframe: Month 6,9,12 and 24

,
Interventionparticipants (Number)
6 Months9 Months12 Months24 Months
Itacitinib Plus Corticosteroids36465156
Placebo Plus Corticosteroids37455252

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Objective Response Rate

(NCT03139604)
Timeframe: Days 14, 56 and 100

,
Interventionparticipants (Number)
Day 14Day 56Day 100
Itacitinib Plus Corticosteroids17013892
Placebo Plus Corticosteroids16012496

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Proportion of Subjects Who Discontinue Corticosteroids

Average and cumulative corticosteroid dose usage will be calculated and proportion of subjects discontinuing corticosteroids will be tabulated (NCT03139604)
Timeframe: Days 28, 56, 100, and 180

,
Interventionparticipants (Number)
Day 28Day 56Day 100Day 180
Itacitinib Plus Corticosteroids3163939
Placebo Plus Corticosteroids3114545

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Proportion of Subjects Who Discontinue Immunosuppressive Medications

Summary statistics of subjects discontinuing immunosuppressive medications will be calculated (NCT03139604)
Timeframe: Days 56 and 100

,
Interventionparticipants (Number)
Day 56Day 100
Itacitinib Plus Corticosteroids1211
Placebo Plus Corticosteroids108

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CL/F of Itacitinib When Administered in Combination With Corticosteroids

Defined as oral dose clearance. (NCT03139604)
Timeframe: Protocol-defined timepoints up to Day 28

InterventionL/h (Mean)
Itacitinib Plus Corticosteroids104

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AUC of Itacitinib When Administered in Combination With Corticosteroids

Defined as area under the concentration-time curve. (NCT03139604)
Timeframe: Protocol-defined timepoints up to Day 28

InterventionnM*h (Mean)
Itacitinib Plus Corticosteroids6720

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Number of Participants With Prolonged Mechanical Ventilation (Greater Than 7 Days)

(NCT03229538)
Timeframe: Until hospital discharge, up to 4 months

InterventionParticipants (Count of Participants)
Methylprednisolone Arm41
Placebo Arm51

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Number of Participants With a Post-operative Length of Stay Greater Than 90 Days

Calculated as discharge date minus surgery date. (NCT03229538)
Timeframe: Until hospital discharge, up to 4 months

InterventionParticipants (Count of Participants)
Methylprednisolone Arm18
Placebo Arm29

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Number of Participants With Any Other Post-operative Complications From the Start of Study Drug Administration Until Hospital Discharge.

(NCT03229538)
Timeframe: Until hospital discharge, up to 4 months

InterventionParticipants (Count of Participants)
Methylprednisolone Arm237
Placebo Arm264

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Number of Participants With Death or Major Complication as Defined by an Outcome in One of the 7 Highest Global Ranking Categories

The 7 highest global ranking categories range from 91 (postoperative length of hospital stay > 90 days) to 97 (operative mortality). (NCT03229538)
Timeframe: Until hospital discharge, up to 4 months

InterventionParticipants (Count of Participants)
Methylprednisolone Arm103
Placebo Arm122

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Number of Participants With Mortality, Including In-hospital Mortality or Mortality After Hospital Discharge But Within 30 Days of the Last Dose of Study Drug

(NCT03229538)
Timeframe: up to 30 days

InterventionParticipants (Count of Participants)
Methylprednisolone Arm12
Placebo Arm17

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Number of Participants With Occurrence of Any One or More of the Following STS-CHSD-defined Major Post-operative Infectious Complications: Postprocedural Infective Endocarditis, Pneumonia, Sepsis, Deep Wound Infection, Mediastinitis.

(NCT03229538)
Timeframe: Until hospital discharge, up to 4 months

InterventionParticipants (Count of Participants)
Methylprednisolone Arm31
Placebo Arm24

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Number of Participants With Post-operative Low Cardiac Output Syndrome

"Based upon the STS-CHSD registry defined cardiac dysfunction resulting in low cardiac output complication variable." (NCT03229538)
Timeframe: Until hospital discharge, up to 4 months

InterventionParticipants (Count of Participants)
Methylprednisolone Arm31
Placebo Arm37

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Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1

"Conjunctival Redness was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no redness) to 4=severe (worst/most redness)).~The conjunctival redness was averaged across all subjects at each time point." (NCT03320434)
Timeframe: post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 1.

,,,
Interventionunits on a scale (Mean)
7 minutes post-CAC15 minutes post-CAC20 minutes post-CAC
Patanol1.5921.8331.917
PRT-2761 0.5%1.2821.4111.371
PRT-2761 0%1.9572.1812.164
PRT-2761 1%1.4911.5261.603

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Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1

Ocular Itching was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no itching) to 4=severe (worst/most itching). The ocular itching was averaged across all subjects at each time point. (NCT03320434)
Timeframe: post CAC exposure at 5, 7, and 10 minutes post CAC on Day 1

,,,
Interventionunits on a scale (Mean)
5 minutes post-CAC7 minutes post-CAC10 minutes post-CAC
Patanol1.2171.3581.258
PRT-2761 0.5%2.5732.6772.250
PRT-2761 0%2.6472.6292.190
PRT-2761 1%2.5002.5092.293

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Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 15

"Conjunctival Redness was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no redness) to 4=severe (worst/most redness)).~The conjunctival redness was averaged across all subjects at each time point." (NCT03320434)
Timeframe: post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 15.

,,,
Interventionunits on a scale (Mean)
7 minutes post-CAC15 minutes post-CAC20 minutes post-CAC
Patanol1.2421.6171.592
PRT-2761 0.5%1.7231.9201.857
PRT-2761 0%1.9731.9912.036
PRT-2761 1%2.0562.1762.222

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Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 15

Ocular Itching was assessed by the subjects using a 0 to 4 point scale(0=none (best/no itching) to 4=severe (worst/most itching)). The ocular itching was averaged across all subjects at each time point. (NCT03320434)
Timeframe: post CAC exposure at 5, 7, and 10 minutes post CAC on Day 15

,,,
Interventionunits on a scale (Mean)
5 minutes post-CAC7 minutes post-CAC10 minutes post-CAC
Patanol0.7750.8080.833
PRT-2761 0.5%2.4312.3621.922
PRT-2761 0%2.5272.3661.929
PRT-2761 1%2.6112.6022.204

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Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24

MFIS is a structured, self-report questionnaire consisting of 21 items assessing the effects of fatigue. All 21 items are scaled 0 to 4, with higher scores indicating a greater impact of fatigue on participant's activities. The Total MFIS score ranges from 0 to 84. A score of 0 indicates fatigue has no impact on activities and the high-end score indicates fatigue has extreme impact on activities. Participant wise data was reported for this outcome. (NCT03387046)
Timeframe: Week 8, 12 and 24

Interventionunits on a scale (Number)
Participant 6: Week 8Participant 7: Week 8Participant 6: Week 12Participant 7: Week 12Participant 7: Week 24
Placebo + IFN Beta-1a + Methylprednisolone2729273043

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Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)

TMS is an electrophysiological technique that was used to measure neurologic changes associated with recovery from stroke via alterations in the excitability of the motor system. Motor threshold measures reflect global excitability of the corticospinal pathway, including large pyramidal cells, excitatory/inhibitory interneurons, and spinal motor neurons. Long term potentiation can be measured non invasively and painlessly, in awake humans through transcranial magnetic stimulation (TMS). TMS uses high intensity, brief duration, magnetic fields that, when applied on the scalp, can activate neurons within a small focal region of the cerebral cortex, through electromagnetic induction. Motor Evoked Potentials (MEP) amplitudes elicited by single TMS pulses of increasing intensity (110, 120 and 130% of the Resting Motor Threshold [RMT]) will be measured to calculate recruitment curves of the motor cortex. Participant wise data was reported for this outcome. (NCT03387046)
Timeframe: Baseline (0 minute) and Post-Baseline (15 minutes) at Week 8

Interventionmillivolts (Number)
Participants 6: Week 8 (Baseline): 110% RMTParticipants 6: Week 8 (Baseline): 120% RMTParticipants 6: Week 8 (Baseline): 130% RMTParticipants 6: Week 8 (Post-baseline): 110% RMTParticipants 6: Week 8 (Post-baseline): 120% RMTParticipants 6: Week 8 (Post-baseline): 130% RMTParticipants 7: Week 8 (Baseline): 110% RMTParticipants 7: Week 8 (Baseline): 120% RMTParticipants 7: Week 8 (Baseline): 130% RMTParticipants 7: Week 8 (Post-baseline): 110% RMTParticipants 7: Week 8 (Post-baseline): 120% RMTParticipants 7: Week 8 (Post-baseline): 130% RMT
Placebo + IFN Beta-1a + Methylprednisolone288311826911253314014930135138

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Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)

TMS is an electrophysiological technique that was used to measure neurologic changes associated with recovery from stroke via alterations in the excitability of the motor system. Motor threshold measures reflect global excitability of the corticospinal pathway, including large pyramidal cells, excitatory/inhibitory interneurons, and spinal motor neurons. Long term potentiation can be measured non invasively and painlessly, in awake humans through transcranial magnetic stimulation (TMS). TMS uses high intensity, brief duration, magnetic fields that, when applied on the scalp, can activate neurons within a small focal region of the cerebral cortex, through electromagnetic induction. Motor Evoked Potentials (MEP) amplitudes elicited by single TMS pulses of increasing intensity (110, 120 and 130% of the Resting Motor Threshold [RMT]) will be measured to calculate recruitment curves of the motor cortex. Participant wise data was reported for this outcome. (NCT03387046)
Timeframe: Baseline (0 minute) and Post-Baseline (15 minutes) at Week 8

Interventionmillivolts (Number)
Participants 1: Week 8 (Baseline): 110% RMTParticipants 1: Week 8 (Baseline): 120% RMTParticipants 1: Week 8 (Baseline): 130% RMTParticipants 1: Week 8 (Post-baseline): 110% RMTParticipants 1: Week 8 (Post-baseline): 120% RMTParticipants 1: Week 8 (Post-baseline): 130% RMTParticipants 3: Week 8 (Baseline): 110% RMTParticipants 3: Week 8 (Baseline): 120% RMTParticipants 3: Week 8 (Baseline): 130% RMTParticipants 3: Week 8 (Post-baseline): 110% RMTParticipants 3: Week 8 (Post-baseline): 120% RMTParticipants 3: Week 8 (Post-baseline): 130% RMT
D-aspartate + IFN Beta-1a + Methylprednisolone3010514239128154239511531103118

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Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24

Fatigue Severity Scale (FSS) is a method of evaluating fatigue in multiple sclerosis and is designed to differentiate fatigue from clinical depression, since both share some of the same symptoms. The Fatigue Severity Scale is a 9-item questionnaire developed to assess the level of fatigue due to neurological disease, were each assessed on a 1-7 scale (1= no fatigue and 7= severe fatigue). The total score was calculated as the average of individual 9-items and ranged from 1 to 7 with a higher value indicating greater impairment due to fatigue. Participant wise data was reported for this outcome. (NCT03387046)
Timeframe: Week 8, 12 and 24

Interventionunits on a scale (Number)
Participant 6: Week 8Participant 7: Week 8Participant 6: Week 12Participant 7: Week 12Participant 7: Week 24
Placebo + IFN Beta-1a + Methylprednisolone4.32.24.14.13.3

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Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24

Fatigue Severity Scale (FSS) is a method of evaluating fatigue in multiple sclerosis and is designed to differentiate fatigue from clinical depression, since both share some of the same symptoms. The Fatigue Severity Scale is a 9-item questionnaire developed to assess the level of fatigue due to neurological disease, were each assessed on a 1-7 scale (1= no fatigue and 7= severe fatigue). The total score was calculated as the average of individual 9-items and ranged from 1 to 7 with a higher value indicating greater impairment due to fatigue. Participant wise data was reported for this outcome. (NCT03387046)
Timeframe: Week 8, 12 and 24

Interventionunits on a scale (Number)
Participant 1: Week 8Participant 2: Week 8Participant 3: Week 8Participant 4: Week 8Participant 5: Week 8Participant 1: Week 12Participant 3: Week 12Participant 4: Week 12Participant 5: Week 12Participant 1: Week 24Participant 3: Week 24Participant 4: Week 24Participant 5: Week 24
D-aspartate + IFN Beta-1a + Methylprednisolone1.22.61.71.111.32.6211.32.821.1

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Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24

MFIS is a structured, self-report questionnaire consisting of 21 items assessing the effects of fatigue. All 21 items are scaled 0 to 4, with higher scores indicating a greater impact of fatigue on participant's activities. The Total MFIS score ranges from 0 to 84. A score of 0 indicates fatigue has no impact on activities and the high-end score indicates fatigue has extreme impact on activities. Participant wise data was reported for this outcome. (NCT03387046)
Timeframe: Week 8, 12 and 24

Interventionunits on a scale (Number)
Participant 1: Week 8Participant 2: Week 8Participant 3: Week 8Participant 4: Week 8Participant 5: Week 8Participant 1: Week 12Participant 3: Week 12Participant 4: Week 12Participant 5: Week 12Participant 1: Week 24Participant 3: Week 24Participant 4: Week 24Participant 5: Week 24
D-aspartate + IFN Beta-1a + Methylprednisolone82715218612121510481215

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Hospital Stay

from operation to discharge (NCT03403517)
Timeframe: 3 months

Interventionhours (Median)
Methylprednisolone98
Dexamethasone102

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Complications, Post-anesthesia Care Unit (PACU)

Number of patients with any complication at any time, during stay in the PACU. Complications according to DASAIMS discharge criteria (modified Aldrete criteria) (NCT03403517)
Timeframe: up to 24 hours

InterventionParticipants (Count of Participants)
Methylprednisolone51
Dexamethasone58

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Mortality

any cause mortality (NCT03403517)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Methylprednisolone0
Dexamethasone0

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PACU Stay

from operation to discharge from PACU (NCT03403517)
Timeframe: up to 24 hours

Interventionminutes (Median)
Methylprednisolone203
Dexamethasone186

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Total Complication Rate

any complications, 30 day morbidity (NCT03403517)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Methylprednisolone19
Dexamethasone19

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Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP)

Measurement of the pressure inside the eye in mmHg, recorded as the change from baseline (NCT03578276)
Timeframe: Month 1

InterventionmmHg (Mean)
LessDrops-0.33
Standard of Care-0.21

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Change From Baseline (Preoperative Exam) in Macular Thickness

Thickness of the macula measured in microns, recorded as the change from baseline. (NCT03578276)
Timeframe: Month 1

Interventionmicrons (Mean)
LessDrops4.91
Standard of Care1.30

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Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness)

Thickness of the cornea measured in microns, measured as the change from baseline (NCT03578276)
Timeframe: Month 1

Interventionmicrons (Mean)
LessDrops3.18
Standard of Care0.63

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Change in Skin Score by mRSS

Defined by at least a 25% improvement (decline) in skin score by modified Rodnan skin score (mRSS) if skin score is greater than 14 on enrollment. If skin score is less than 14 on enrollment, improvement is defined by at least a 5% improvement on mRSS. The modified Rodnan skin score (MRSS) is a measure for skin disease in scleroderma and is calculated by summation of skin thickness in 17 different body sites. The scale ranges from at total score of normal skin thickness (0) to severe thickness (51). (NCT03593902)
Timeframe: Pre Treatment and Post Treatment

Interventionunits on a scale (Mean)
Pre TreatmentPost Treatment
Hematopoietic Stem Cell Transplantation2516

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Survival of Treatment

Survival of Hematopoietic Stem Cell Transplant during treatment and post treatment up to 1 year. (NCT03593902)
Timeframe: During Treatment and Post Treatment up to 1 year

InterventionParticipants (Count of Participants)
Hematopoietic Stem Cell Transplantation9

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Visual Analog Pain Scale (VAS-pain) Daily Until Post-injection Day 7

Participants were instructed to log their pain twice daily (morning and night) using a VAS pain scale of 0-10 (0: no pain, 10: highest amount of pain) for the first 7 days after injection. Participants were instructed to bring that pain journal to their 2-week visit. Average daily scores are presented. (NCT03704584)
Timeframe: Post injection day (1-7), 2 weeks and at 6 weeks post intervention

,
Interventionscore on a scale (Mean)
Post injection day 1Post injection day 2Post injection day 3Post injection day 4Post injection day 5Post injection day 6Post injection day 7
Control Group (Corticosteroid Alone)3.73.02.62.22.01.51.6
Treatment Group (Corticosteroid Injection Plus Lidocaine)3.72.21.71.11.00.690.58

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10 Point Likert Scale of Pain Scores Before the Injection and After the Injection and During Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group

Pain will be assessed with a 10-point scale (0: no pain, 10: highest amount of pain) of anticipated pain and anxiety before injection and a 10-point pain scale of the pain of the needle, medication, overall pain and anxiety after the injection was administered to the participants. (NCT03704584)
Timeframe: Pre injection, Post injection day, 2 weeks and at 6 weeks

,
Interventionscore on a scale (Mean)
Pre-Injection: How painful do you think the injection will be?Pre-Injection: How painful do you think it will be 1-minute after the injection?Pre-Injection: How nervous are you about the injection?Post-Injection: Actual pain of the needlePost-Injection: Actual pain of the medicationPost-Injection: Actual pain 1-minute after the injection
Control Group (Corticosteroid Alone)5.43.23.54.24.31.7
Treatment Group (Corticosteroid Injection Plus Lidocaine)5.94.44.04.34.71.7

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Number of Patients With Subsequent Reinjection and Surgical Operation

The number of patients with subsequent reinjection and surgical operation was collected during follow up. (NCT03704584)
Timeframe: End of follow up (6 weeks post intervention)

InterventionParticipants (Count of Participants)
Treatment Group (Corticosteroid Injection Plus Lidocaine)0
Control Group (Corticosteroid Alone)0

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Number of Participants Who Are Eligible, Consent, and Complete the 48 Weeks Study

To establish acceptability of this treatment approach assessing proportion of patients who are eligible, consent and complete the 48 week study. We will examine how many patients in the MONITOR cohort are eligible per year. All eligible patients in the MONITOR cohort will be approached and invited to join the study. We will then review how many patients complete the 48 week study period attending all visits from baseline to 48 weeks (0, 12, 24, 36 and 48). (NCT03797872)
Timeframe: 48 weeks

InterventionParticipants (Count of Participants)
Standard Care0

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Occurrence of Hyperglycemia

Number of participants who have hyperglycemia while receiving corticosteroids. Hyperglycemia is defined as a consistently elevated blood sugar level requiring insulin administration. (NCT03852537)
Timeframe: Up to day +5 following study enrollment.

InterventionParticipants (Count of Participants)
Usual Care11
Biomarker-adjusted Steroid Dosing18

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Occurrence of Secondary Infection

Number of participants who develop secondary infections during and after steroid therapy. A secondary infection is defined as a new infection that develops after initiation of corticosteroid therapy, until 5 days after steroids are discontinued. (NCT03852537)
Timeframe: Up to day +14 following study enrollment.

InterventionParticipants (Count of Participants)
Usual Care0
Biomarker-adjusted Steroid Dosing0

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Oxygen-free Days

Number of days subjects did not require oxygen assistance. (NCT03852537)
Timeframe: Within hospitalization or 30 days of study enrollment (whichever is sooner)

Interventiondays (Median)
Usual Care21.0
Biomarker-adjusted Steroid Dosing24.0

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Timely Initiation of Corticosteroids and Implementation of Biomarker-titrated Corticosteroid Dosing

Number of eligible subjects to adhered to the timely initiation and daily corticosteroid treatment according to ESICM/Society of Critical Care Medicine SCCM clinical practice guideline (control group) or biomarker concordance (intervention group) (NCT03852537)
Timeframe: Within 30 days of enrollment in study.

InterventionParticipants (Count of Participants)
Usual Care20
Biomarker-adjusted Steroid Dosing19

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Organ Failure

Organ failures measured by Sequential Organ Failure Assessment (SOFA). The overall score is based on 6 sub-scores respiratory system, neurologic system, cardiovascular system, hepatic system, coagulation, and renal system using an overall scale of 0-24, which 0=no organ failure, 24=complete organ failure. (NCT03852537)
Timeframe: Measured daily for approximately 5 days

,
Interventionscore on a scale (Median)
Day 1Day 2Day 3Day 4Day 5
Biomarker-adjusted Steroid Dosing7.03.03.03.05.5
Usual Care3.03.03.03.03.0

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ICU Admission

Number of subjects admitted to the ICU (NCT03852537)
Timeframe: Within hospitalization or 30 days of study enrollment (whichever is sooner)

InterventionParticipants (Count of Participants)
Usual Care10
Biomarker-adjusted Steroid Dosing5

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Cardiovascular Dysfunction

Number of subjects with new and/or worsening right ventricle (RV)/left ventricle (LV) dysfunction (NCT03852537)
Timeframe: Within hospitalization or 30 days of study enrollment (whichever is sooner)

InterventionParticipants (Count of Participants)
Usual Care1
Biomarker-adjusted Steroid Dosing1

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Mortality

Number of subject deaths (NCT03852537)
Timeframe: 90 days

InterventionParticipants (Count of Participants)
Usual Care1
Biomarker-adjusted Steroid Dosing1

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Myocardial Injury

Number of participants with evidence of myocardial injury determined by daily troponin peak and /or new diagnosis of Left Ventricular (LV) dysfunction (LVEF <40%) or new diagnosis of cor pulmonale (NCT03852537)
Timeframe: Up to day +14 following study enrollment.

InterventionParticipants (Count of Participants)
Usual Care8
Biomarker-adjusted Steroid Dosing10

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Need for High Flow Nasal Cannula Oxygen

Number of subjects to need high flow nasal cannula oxygen (NCT03852537)
Timeframe: Within hospitalization or 30 days of study enrollment (whichever is sooner)

InterventionParticipants (Count of Participants)
Usual Care7
Biomarker-adjusted Steroid Dosing4

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Need for Invasive Mechanical Ventilation

Assessed by the number of participants that required invasive mechanical ventilation. (NCT03852537)
Timeframe: Within hospitalization or 30 days of study enrollment (whichever is sooner)

InterventionParticipants (Count of Participants)
Usual Care3
Biomarker-adjusted Steroid Dosing2

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Need for Noninvasive Mechanical Ventilation

Assessed by the number of participants that required noninvasive mechanical ventilation. (NCT03852537)
Timeframe: Within hospitalization or 30 days of study enrollment (whichever is sooner)

InterventionParticipants (Count of Participants)
Usual Care4
Biomarker-adjusted Steroid Dosing2

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New Onset Cardiac Arrhythmias

Number of participants who develop arrhythmias identified by electrocardiogram or echocardiogram. (NCT03852537)
Timeframe: Within hospitalization or 30 days of study enrollment (whichever is sooner)

InterventionParticipants (Count of Participants)
Usual Care0
Biomarker-adjusted Steroid Dosing1

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Occurrence of Delirium

Number of participants who develop delirium while receiving corticosteroids. Delirium will be assessed by Confusion Assessment Method for the ICU (CAM-ICU) measurement tool. The CAM-ICU is a binary (yes/no) scale for assessing the presence of delirium. (NCT03852537)
Timeframe: Up to day +5 following study enrollment.

InterventionParticipants (Count of Participants)
Usual Care5
Biomarker-adjusted Steroid Dosing5

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Percentage of Participants With Biopsy Proven Acute Rejection (BPAR)

Histological grading of acute allograft rejection from biopsy specimens was based on Banff criteria 2017. Grade IA: Moderate tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade IB: Severe tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade II. Arterial intimal fibrosis with mononuclear cell inflammation, formation of neointima. (NCT04046549)
Timeframe: Week 12, 24, 48

Interventionpercentage of participants (Number)
Week 12Week 24Week 48
Belatacept+VIB492025.025.025.0

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Percentage of Participants With Antibody-Mediated Rejection

The diagnosis of antibody-mediated rejection was based on Banff criteria 2017 - a set of standardized guidelines used by pathologists and clinicians to diagnose and classify rejection based on specific features observed in biopsy samples from the transplanted organ, such as the presence of certain types of immune cells, inflammation, and injury patterns. (NCT04046549)
Timeframe: Week 12, 24, 48

Interventionpercentage of participants (Number)
Week 12Week 24Week 48
Belatacept+VIB492010.010.015.0

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Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR), Graft Loss, Death or Loss to Follow-up (LTFU)

Histological grading of acute allograft rejection from biopsy specimens was based on Banff criteria 2017. Grade IA: Moderate tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade IB: Severe tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade II. Arterial intimal fibrosis with mononuclear cell inflammation, formation of neointima. (NCT04046549)
Timeframe: Week 12, 24, 48

Interventionpercentage of participants (Number)
Week 12Week 24Week 48
Belatacept+VIB492025.025.025.0

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Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR) of Grade 1A or Higher, Graft Loss or Death at Weeks 12 and 48

Histological grading of acute allograft rejection from biopsy specimens was based on Banff criteria 2017. Grade IA: Moderate tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade IB: Severe tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade II. Arterial intimal fibrosis with mononuclear cell inflammation, formation of neointima. (NCT04046549)
Timeframe: Weeks 12 and 48

Interventionpercentage of participants (Number)
Week 12Week 48
Belatacept+VIB492025.025.0

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Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR)

Histological grading of acute allograft rejection from biopsy specimens was based on Banff criteria 2017. Grade IA: Moderate tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade IB: Severe tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade II. Arterial intimal fibrosis with mononuclear cell inflammation, formation of neointima. tBPAR was defined as a BPAR which was treated with anti-rejection therapy. (NCT04046549)
Timeframe: Week 12, 24, 48

Interventionpercentage of participants (Number)
Week 12Week 24Week 48
Belatacept+VIB492025.025.025.0

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Percentage of Participants With Treated Acute Rejections

Acute rejections, per clinical judgement of the investigator followed by confirmatory biopsy, were treated with bolus methylprednisolone (other corticosteroids were acceptable at an equivalent dose) according to local practice. (NCT04046549)
Timeframe: Week 12, 24, 48

Interventionpercentage of participants (Number)
Week 12Week 24Week 48
Belatacept+VIB492025.025.030.0

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Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR) of Grade 1A or Higher, Graft Loss or Death at Week 24

Histological grading of acute allograft rejection from biopsy specimens was based on Banff criteria 2017. Grade IA: Moderate tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade IB: Severe tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade II. Arterial intimal fibrosis with mononuclear cell inflammation, formation of neointima. (NCT04046549)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Belatacept+VIB492025.0

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Evaluation of Intraoperative Use of Dexycu on Tear Film Osmolarity at 3 Weeks Postoperatively

Tear Film Osmolarity as measured on Tear Lab system; validated measure of Tear Film Osmolarity Osmolarity was reported in milliosmoles per liter (mOsmol/L) (NCT04184999)
Timeframe: 3 weeks

InterventionmOsmol/L (Mean)
Intracameral Dexamethasone311.15
Postoperative Prednisolone Acetate316.3

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Number of SLE Patients That Were Sampled for RNA-seq Differential Expression Analysis (Biological Replicates)

Number of of SLE patients that were sampled for RNA-seq differential gene expression analysis in glucocorticoid-treated immune cells. The analysis employed a cutoff value of < 5% false-discovery rate (FDR) to select the transcripts that were considered differentially expressed at each time point. The resulting gene lists were contrasted to determine which genes were uniquely differentially expressed in different cell types. (NCT04233164)
Timeframe: 2 hours and 4 hours post infusion

,
InterventionParticipants (Count of Participants)
2 hours post infusion4 hours post infusion
Group A: Glucocorticoids 1 mg/kg Dose2020
Group B: Glucocorticoids 250 mg Dose2020

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Endotracheal Intubation (Invasive Mechanical Ventilation)

We reported below the number of participants who needed endotracheal intubation during ICU admission (NCT04323592)
Timeframe: 28 days

InterventionParticipants (Count of Participants)
Exposed to Methylprednisolone15
Non-exposed to Methylprednisolone26

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In-hospital Death Within 28 Days

We reported below the number of participants who died within 28 days, during the hospital stay. (NCT04323592)
Timeframe: 28 days

InterventionParticipants (Count of Participants)
Exposed to Methylprednisolone6
Non-exposed to Methylprednisolone21

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Number of Days Free From Mechanical Ventilation

number of days free from mechanical ventilation (both invasive and non-invasive) by day 28 (NCT04323592)
Timeframe: 28 days

Interventiondays (Mean)
Exposed to Methylprednisolone19.11
Non-exposed to Methylprednisolone14.34

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Admission to Intensive Care Unit (ICU)

We reported below the number of participants admitted to ICU within 28 days. (NCT04323592)
Timeframe: 28 days

InterventionParticipants (Count of Participants)
Exposed to Methylprednisolone15
Non-exposed to Methylprednisolone27

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Change in C-reactive Protein (CRP)

Change in C-reactive protein after 7 days from baseline. A reduction of CRP reveals a laboratory improvement. (NCT04323592)
Timeframe: 7 days

Interventionmg/L (Mean)
Exposed to Methylprednisolone-82.08
Non-exposed to Methylprednisolone-34.34

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Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation (MV), or All-cause Death by Day 28

We reported below the number of participants meeting at least one of three among death or ICU admission or Invasive mechanical ventilation. (NCT04323592)
Timeframe: 28 days

InterventionParticipants (Count of Participants)
Exposed to Methylprednisolone19
Non-exposed to Methylprednisolone40

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Number of Lines Lost From Best Corrected Visual Acuity

After manifest refraction all units assessed for best corrected distance visual acuity using ETDRS. Number of lines seen was then converted to LogMar score (on a scale of -0.30 to 1.00 where smaller numbers indicate better vision and larger numbers indicate worse vision) to measure changes in Best Corrected Distance Visual Acuity between Baseline and Day 90 (NCT04380857)
Timeframe: Baseline through Day 90

InterventionScore on a scale (Mean)
Dexamethasone Ophthalmic Insert 0.4 mg0
Topical Prednisolone Acetate Ophthalmic Drops0

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Patient Preference Between Groups

As reported by patients choosing one of five options; Strongly preferred insert, preferred insert, no preference, preferred standard drop regimen, strongly preferred standard drop regimen. (NCT04380857)
Timeframe: Day 7, Day 30 and Day 90

,,
InterventionParticipants (Count of Participants)
Day 7Day 30Day 90
Dexamethasone Ophthalmic Insert 0.4 mg14119
No Preference435
Topical Prednisolone Acetate Ophthalmic Drops233

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Loss of Lines in Uncorrected Visual Acuity

All units assessed for uncorrected visual acuity using ETDRS. Number of lines seen was then converted to LogMar to measure changes in uncorrected visual acuity between Baseline and Day 90. (NCT04380857)
Timeframe: Baseline to Day 7, Day 30 and Day 90

,
InterventionlogMAR (Mean)
1 week1 month3 months
Dexamethasone Ophthalmic Insert 0.4 mg-0.010-0.014-0.071
Topical Prednisolone Acetate Ophthalmic Drops0.013-0.026-0.068

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Mean Change in Pain

"post-op pain as measured as scores on an Ocular Pain Assessment Scale from 0-10 (0 being no pain and 10 being the worst pain you could imagine)" (NCT04380857)
Timeframe: Change is being assessed at Baseline, Day 1, Day 7, Day 30 and Day 90

,
InterventionScore on a scale from 0-10 (Mean)
Pre-operativeDay 1Day 7Day 30Day 90
Dexamethasone Ophthalmic Insert 0.4 mg0.150.950.470.410
Topical Prednisolone Acetate Ophthalmic Drops0.200.900.370.060

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Post op Pain Management Per Eye

Count of participants requiring pain management from Day 0 to Day 90. (NCT04380857)
Timeframe: Day 0 to Day 90

InterventionEyes (Count of Units)
Dexamethasone Ophthalmic Insert 0.4 mg0
Topical Prednisolone Acetate Ophthalmic Drops0

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Intensity of Pain

Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever (NCT04900220)
Timeframe: Up to 7 days

,
Interventionscore on a scale (Mean)
BaselineFive MinutesDay 1Day 2Day 3Day 4Day 5Day 6Day 7
Betamethasone2.80.31.41.31.00.70.60.60.5
Methylprednisolone2.10.82.92.11.51.00.80.70.6

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Incidence of Pain

Recorded when subject reports pain. Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever (NCT04900220)
Timeframe: Up to 7 days

InterventionParticipants (Count of Participants)
Betamethasone6
Methylprednisolone11

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Patient Reported Outcome Measures: Overall Assessment of Knee After Surgery and Treatment

Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR), a survey given to patients standard of care containing 7 questions. The score ranges from 0 to 100 where zero represents total disability and 100 represents a perfect knee health. (NCT05113901)
Timeframe: 6 weeks after treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper72.12

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Patient Reported Outcome Measures: Overall Assessment of Knee After Surgery and Treatment

Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR), a survey given to patients standard of care containing 7 questions. The score ranges from 0 to 100 where zero represents total disability and 100 represents a perfect knee health. (NCT05113901)
Timeframe: pre treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper50.04

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Patient Reported Outcome Measures: Overall Assessment of Knee Before Treatment

Single Assessment Numeric Evaluation (SANE), a single-question patient rating of 0-100, scoring their function to the area being treated. Zero represents a poor functional knee and 100 is the best functioning. (NCT05113901)
Timeframe: pre treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper29.5

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Patient Reported Outcome Measures: Overall Assessment of Knee Before Treatment

Veterans Rand 12-Item Health Survey (VR-12), a survey of 12 questions to measure health relating to patient's quality of life. Scored as summary of mental and physical, measure in standard deviations. The scale range is 0 to 100, where a score of 100 represents the best physical and mental health and zero is the worst outcome. (NCT05113901)
Timeframe: pre treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper38.73

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Patient Reported Outcome Measures: Overall Assessment of Knee Prior to Treatment

Forgotten Joint Score (FJS) is a survey scored ranging from 0 to 100, where a high score indicates a high degree of a forgetting they have an artificial joint, which is an ideal outcome. (NCT05113901)
Timeframe: pre treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper91.67

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Patient Reported Outcome Measures: Overall Assessment of Knee Prior to Treatment

UCLA activity score, on a scale of 1 to 10 where 10 is the most active patient with examples of activities (NCT05113901)
Timeframe: pre treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper4.25

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Patient Reported Outcome Measures: Post Treatment Pain Scores

"Knee society score (KSS); done standard of care on a scale of 0-100, where 100 means a more functional knee.~**Please note, the study was terminated early, only 4 subjects were enrolled and none were randomized to the placebo group. At 3 weeks post treatment, only 3 of the 4 subjects enrolled were still part of the study." (NCT05113901)
Timeframe: 3 weeks post treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper68.33

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Patient Reported Outcome Measures: Post Treatment Pain Scores

"Knee society score (KSS); done standard of care on a scale of 0-100, where 100 means a more functional knee.~**Please note, the study was terminated early, only 4 subjects were enrolled and none were randomized to the placebo group. This is a standard of care survey available on all subjects." (NCT05113901)
Timeframe: 6 weeks post treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper78.75

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Patient Reported Outcome Measures: Pre Treatment Pain Scores Using Knee Society Scores

"Knee society score (KSS); done standard of care on a scale of 0-100, where 100 means a more functional knee~**Please note, the study was terminated early, only 4 subjects were enrolled and none were randomized to the placebo group." (NCT05113901)
Timeframe: pre treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper66.25

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Patient Reported Outcome Measures: Post Treatment Pain Scores (6 Weeks)

"Using daily defense and veterans pain rating scale (DVPRS) on a scale of 1 to 10, 10 being the worst.~Please note, only one patient made it to the 6 week post treatment mark of the 4 enrolled. The study was terminated and none of the patients were randomized to the placebo group. All other patients followed up but were not interested in continuing. No range could be provided given only one subject answered and completed this visit" (NCT05113901)
Timeframe: 6 weeks post treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper1.93

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Adverse Events or Outcomes Outside of Manipulations Under Anesthesia

Adverse outcomes including infection, avascular necrosis, and 90-day readmission rates (NCT05113901)
Timeframe: within 90 days after initial total knee arthroplasty

InterventionParticipants (Count of Participants)
Methylprednisolone Taper0
Placebo Taper0

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Number of Participants With Complications Following Treatment

Manipulations under anesthesia (MUAs) following total knee arthroplasty surgery and treatment (NCT05113901)
Timeframe: within 90 days after initial total knee arthroplasty

InterventionParticipants (Count of Participants)
Methylprednisolone Taper0
Placebo Taper0

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Patient Reported Outcome Measures: Overall Assessment of Knee 6 Weeks After Treatment

Single Assessment Numeric Evaluation (SANE), a single-question patient rating of 0-100, scoring their function to the area being treated. Zero represents a poor functional knee and 100 is the best functioning. (NCT05113901)
Timeframe: 6 weeks after treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper89.5

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Patient Reported Outcome Measures: Overall Assessment of Knee 6 Weeks After Treatment

UCLA activity score, on a scale of 1 to 10 where 10 is the most active patient with examples of activities (NCT05113901)
Timeframe: 6 weeks after treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper5.25

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Patient Reported Outcome Measures: Overall Assessment of Knee 6 Weeks After Treatment

VR-12: Assesses physical functioning, physical/ mental limitations. Scored as summary of mental and physical, measure in standard deviations. The scale range is 0 to 100, where a score of 100 represents the best physical and mental health and zero is the worst outcome. (NCT05113901)
Timeframe: 6 weeks after treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper50.28

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Range of Motion in Degrees at Pre and Post Treatment

"Range of motion (ROM) from pre-treatment to six weeks following treatment. Patients started treatment after total knee replacement surgery and presented to clinic with at least one inclusion criteria to be enrolled. Range of motion in degrees is taken at each visit by a clinician (standard of care), starting at zero degrees (straight leg) to about 135 degrees. The ROM was documented as part of consenting and enrollment into study. Subjects returned to the office at 6 weeks post treatment where ROM was performed in a clinic setting once again and documented. ROM is done using a goniometer by a clinician in each clinic.~This study was terminated early, therefore of the 4 enrolled, zero were randomized to the placebo group. Only 1 of the four subjects completed the 6 weeks, however, ROM was captured on all as standard of care." (NCT05113901)
Timeframe: Baseline, Week 6 Following Treatment

InterventionRange of Motion in Degrees (Mean)
Pre treatmentPost treatment
Methylprednisolone Taper82.5112

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Patient Reported Outcome Measures:(Immediate) Post Treatment Pain Scores

"Using Daily Visual Analogue Scale (VAS) pain score, which measures intensity of pain on a scale of 0 (no pain) to 10 (worst pain possible).~**Please note, this study was terminated early, only enrolling 4 patients, none were randomized to the placebo group." (NCT05113901)
Timeframe: Days 1 through 6 following treatment

Interventionscore on a scale (Mean)
Day 1Day 2Day 3Day 4Day 5Day 6
Methylprednisolone Taper2.3331.331.331.672.3

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Patient Reported Outcome Measures: Overall Assessment of Knee 6 Wks After Treatment

Forgotten Joint Score (FJS) is a survey scored ranging from 0 to 100, where a high score indicates a high degree of a forgetting they have an artificial joint, which is an ideal outcome. (NCT05113901)
Timeframe: 6 weeks after treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper57.82

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SubstanceRelationship StrengthStudiesTrialsClassesRoles
acetic acid
Acetic Acid: Product of the oxidation of ethanol and of the destructive distillation of wood. It is used locally, occasionally internally, as a counterirritant and also as a reagent. (Stedman, 26th ed). acetic acid : A simple monocarboxylic acid containing two carbons.		210monocarboxylic acidantimicrobial food preservative;
Daphnia magna metabolite;
food acidity regulator;
protic solvent
chlorine
chloride : A halide anion formed when chlorine picks up an electron to form an an anion.		1.9910halide anion;
monoatomic chlorine		cofactor;
Escherichia coli metabolite;
human metabolite
phenytoin
[no description available]		2.0310imidazolidine-2,4-dioneanticonvulsant;
drug allergen;
sodium channel blocker;
teratogenic agent
acetaminophen
Acetaminophen: Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.. paracetamol : A member of the class of phenols that is 4-aminophenol in which one of the hydrogens attached to the amino group has been replaced by an acetyl group.		2.0310acetamides;
phenols		antipyretic;
cyclooxygenase 1 inhibitor;
cyclooxygenase 2 inhibitor;
cyclooxygenase 3 inhibitor;
environmental contaminant;
ferroptosis inducer;
geroprotector;
hepatotoxic agent;
human blood serum metabolite;
non-narcotic analgesic;
non-steroidal anti-inflammatory drug;
xenobiotic
alosetron
alosetron : A pyrido[4,3-b]indole compound having a 5-methyl-1H-imidazol-4-ylmethyl group at the 2-position.		2.0310imidazoles;
pyridoindole		antiemetic;
gastrointestinal drug;
serotonergic antagonist
theophylline
[no description available]		2.0310dimethylxanthineadenosine receptor antagonist;
anti-asthmatic drug;
anti-inflammatory agent;
bronchodilator agent;
drug metabolite;
EC 3.1.4.* (phosphoric diester hydrolase) inhibitor;
fungal metabolite;
human blood serum metabolite;
immunomodulator;
muscle relaxant;
vasodilator agent
amiodarone
Amiodarone: An antianginal and class III antiarrhythmic drug. It increases the duration of ventricular and atrial muscle action by inhibiting POTASSIUM CHANNELS and VOLTAGE-GATED SODIUM CHANNELS. There is a resulting decrease in heart rate and in vascular resistance.. amiodarone : A member of the class of 1-benzofurans that is 1-benzofuran substituted by a butyl group at position 2 and a 4-[2-(diethylamino)ethoxy]-3,5-diiodobenzoyl group at position 3. It is a cardiovascular drug used for the treatment of cardiac dysrhythmias.		2.03101-benzofurans;
aromatic ketone;
organoiodine compound;
tertiary amino compound		cardiovascular drug
anastrozole
[no description available]		2.0310nitrile;
triazoles		antineoplastic agent;
EC 1.14.14.14 (aromatase) inhibitor
aspirin
Aspirin: The prototypical analgesic used in the treatment of mild to moderate pain. It has anti-inflammatory and antipyretic properties and acts as an inhibitor of cyclooxygenase which results in the inhibition of the biosynthesis of prostaglandins. Aspirin also inhibits platelet aggregation and is used in the prevention of arterial and venous thrombosis. (From Martindale, The Extra Pharmacopoeia, 30th ed, p5). acetylsalicylate : A benzoate that is the conjugate base of acetylsalicylic acid, arising from deprotonation of the carboxy group.. acetylsalicylic acid : A member of the class of benzoic acids that is salicylic acid in which the hydrogen that is attached to the phenolic hydroxy group has been replaced by an acetoxy group. A non-steroidal anti-inflammatory drug with cyclooxygenase inhibitor activity.		2.0310benzoic acids;
phenyl acetates;
salicylates		anticoagulant;
antipyretic;
cyclooxygenase 1 inhibitor;
cyclooxygenase 2 inhibitor;
drug allergen;
EC 1.1.1.188 (prostaglandin-F synthase) inhibitor;
geroprotector;
non-narcotic analgesic;
non-steroidal anti-inflammatory drug;
plant activator;
platelet aggregation inhibitor;
prostaglandin antagonist;
teratogenic agent
bumetanide
[no description available]		2.0310amino acid;
benzoic acids;
sulfonamide		diuretic;
EC 3.6.3.49 (channel-conductance-controlling ATPase) inhibitor
busulfan
[no description available]		2.0310methanesulfonate esteralkylating agent;
antineoplastic agent;
carcinogenic agent;
insect sterilant;
teratogenic agent
caffeine
[no description available]		2.0310purine alkaloid;
trimethylxanthine		adenosine A2A receptor antagonist;
adenosine receptor antagonist;
adjuvant;
central nervous system stimulant;
diuretic;
EC 2.7.11.1 (non-specific serine/threonine protein kinase) inhibitor;
EC 3.1.4.* (phosphoric diester hydrolase) inhibitor;
environmental contaminant;
food additive;
fungal metabolite;
geroprotector;
human blood serum metabolite;
mouse metabolite;
mutagen;
plant metabolite;
psychotropic drug;
ryanodine receptor agonist;
xenobiotic
verapamil
Verapamil: A calcium channel blocker that is a class IV anti-arrhythmia agent.. verapamil : A racemate comprising equimolar amounts of dexverapamil and (S)-verapamil. An L-type calcium channel blocker of the phenylalkylamine class, it is used (particularly as the hydrochloride salt) in the treatment of hypertension, angina pectoris and cardiac arrhythmia, and as a preventive medication for migraine.. 2-(3,4-dimethoxyphenyl)-5-{[2-(3,4-dimethoxyphenyl)ethyl](methyl)amino}-2-(propan-2-yl)pentanenitrile : A tertiary amino compound that is 3,4-dimethoxyphenylethylamine in which the hydrogens attached to the nitrogen are replaced by a methyl group and a 4-cyano-4-(3,4-dimethoxyphenyl)-5-methylhexyl group.		2.0510aromatic ether;
nitrile;
polyether;
tertiary amino compound
candesartan
candesartan: a nonpeptide angiotensin II receptor antagonist. candesartan : A benzimidazolecarboxylic acid that is 1H-benzimidazole-7-carboxylic acid substituted by an ethoxy group at position 2 and a ({2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl}methyl) group at position 1. It is a angiotensin receptor antagonist used for the treatment of hypertension.		2.0310benzimidazolecarboxylic acid;
biphenylyltetrazole		angiotensin receptor antagonist;
antihypertensive agent;
environmental contaminant;
xenobiotic
carbamazepine
Carbamazepine: A dibenzazepine that acts as a sodium channel blocker. It is used as an anticonvulsant for the treatment of grand mal and psychomotor or focal SEIZURES. It may also be used in the management of BIPOLAR DISORDER, and has analgesic properties.. carbamazepine : A dibenzoazepine that is 5H-dibenzo[b,f]azepine carrying a carbamoyl substituent at the azepine nitrogen, used as an anticonvulsant.		2.3920dibenzoazepine;
ureas		analgesic;
anticonvulsant;
antimanic drug;
drug allergen;
EC 3.5.1.98 (histone deacetylase) inhibitor;
environmental contaminant;
glutamate transporter activator;
mitogen;
non-narcotic analgesic;
sodium channel blocker;
xenobiotic
chlorambucil
Chlorambucil: A nitrogen mustard alkylating agent used as antineoplastic for chronic lymphocytic leukemia, Hodgkin's disease, and others. Although it is less toxic than most other nitrogen mustards, it has been listed as a known carcinogen in the Fourth Annual Report on Carcinogens (NTP 85-002, 1985). (Merck Index, 11th ed). chlorambucil : A monocarboxylic acid that is butanoic acid substituted at position 4 by a 4-[bis(2-chloroethyl)amino]phenyl group. A chemotherapy drug that can be used in combination with the antibody obinutuzumab for the treatment of chronic lymphocytic leukemia.		2.0310aromatic amine;
monocarboxylic acid;
nitrogen mustard;
organochlorine compound;
tertiary amino compound		alkylating agent;
antineoplastic agent;
carcinogenic agent;
drug allergen;
immunosuppressive agent
chlorpromazine
Chlorpromazine: The prototypical phenothiazine antipsychotic drug. Like the other drugs in this class chlorpromazine's antipsychotic actions are thought to be due to long-term adaptation by the brain to blocking DOPAMINE RECEPTORS. Chlorpromazine has several other actions and therapeutic uses, including as an antiemetic and in the treatment of intractable hiccup.. chlorpromazine : A substituted phenothiazine in which the ring nitrogen at position 10 is attached to C-3 of an N,N-dimethylpropanamine moiety.		2.0310organochlorine compound;
phenothiazines;
tertiary amine		anticoronaviral agent;
antiemetic;
dopaminergic antagonist;
EC 3.4.21.26 (prolyl oligopeptidase) inhibitor;
phenothiazine antipsychotic drug
cimetidine
Cimetidine: A histamine congener, it competitively inhibits HISTAMINE binding to HISTAMINE H2 RECEPTORS. Cimetidine has a range of pharmacological actions. It inhibits GASTRIC ACID secretion, as well as PEPSIN and GASTRIN output.. cimetidine : A member of the class of guanidines that consists of guanidine carrying a methyl substituent at position 1, a cyano group at position 2 and a 2-{[(5-methyl-1H-imidazol-4-yl)methyl]sulfanyl}ethyl group at position 3. It is a H2-receptor antagonist that inhibits the production of acid in stomach.		2.0310aliphatic sulfide;
guanidines;
imidazoles;
nitrile		adjuvant;
analgesic;
anti-ulcer drug;
H2-receptor antagonist;
P450 inhibitor
ciprofloxacin
Ciprofloxacin: A broad-spectrum antimicrobial carboxyfluoroquinoline.. ciprofloxacin : A quinolone that is quinolin-4(1H)-one bearing cyclopropyl, carboxylic acid, fluoro and piperazin-1-yl substituents at positions 1, 3, 6 and 7, respectively.		2.9340aminoquinoline;
cyclopropanes;
fluoroquinolone antibiotic;
N-arylpiperazine;
quinolinemonocarboxylic acid;
quinolone antibiotic;
quinolone;
zwitterion		antibacterial drug;
antiinfective agent;
antimicrobial agent;
DNA synthesis inhibitor;
EC 5.99.1.3 [DNA topoisomerase (ATP-hydrolysing)] inhibitor;
environmental contaminant;
topoisomerase IV inhibitor;
xenobiotic
clofibrate
angiokapsul: contains clofibrate & insoitolnicotinate		2.0310aromatic ether;
ethyl ester;
monochlorobenzenes		anticholesteremic drug;
antilipemic drug;
geroprotector;
PPARalpha agonist
clonazepam
Clonazepam: An anticonvulsant used for several types of seizures, including myotonic or atonic seizures, photosensitive epilepsy, and absence seizures, although tolerance may develop. It is seldom effective in generalized tonic-clonic or partial seizures. The mechanism of action appears to involve the enhancement of GAMMA-AMINOBUTYRIC ACID receptor responses.. clonazepam : 1,3-Dihydro-2H-1,4-benzodiazepin-2-one in which the hydrogens at positions 5 and 7 are substituted by 2-chlorophenyl and nitro groups, respectively. It is used in the treatment of all types of epilepsy and seizures, as well as myoclonus and associated abnormal movements, and panic disorders. However, its use can be limited by the development of tolerance and by sedation.		2.03101,4-benzodiazepinone;
monochlorobenzenes		anticonvulsant;
anxiolytic drug;
GABA modulator
clonidine
Clonidine: An imidazoline sympatholytic agent that stimulates ALPHA-2 ADRENERGIC RECEPTORS and central IMIDAZOLINE RECEPTORS. It is commonly used in the management of HYPERTENSION.. clonidine (amino form) : A clonidine that is 4,5-dihydro-1H-imidazol-2-amine in which one of the amino hydrogens is replaced by a 2,6-dichlorophenyl group.		2.0310clonidine;
imidazoline
cyclopentolate
Cyclopentolate: A parasympatholytic anticholinergic used solely to obtain mydriasis or cycloplegia.. cyclopentolate : A carboxylic ester resulting from the formal condensation of (1-hydroxycyclopentyl)(phenyl)acetic acid with N,N-dimethylethanolamine. A tertiary amine antimuscarinic with actions similar to atropine, it is used as its hydrochloride salt to produce mydriasis (excessive dilation of the pupil) and cycloplegia (paralysis of the ciliary muscle of the eye) for opthalmic diagnostic procedures. It acts more quickly than atropine and has a shorter duration of action.		210carboxylic ester;
tertiary alcohol;
tertiary amino compound		diagnostic agent;
muscarinic antagonist;
mydriatic agent;
parasympatholytic
dapsone
[no description available]		2.0310substituted aniline;
sulfone		anti-inflammatory drug;
antiinfective agent;
antimalarial;
leprostatic drug
diazepam
Diazepam: A benzodiazepine with anticonvulsant, anxiolytic, sedative, muscle relaxant, and amnesic properties and a long duration of action. Its actions are mediated by enhancement of GAMMA-AMINOBUTYRIC ACID activity.. diazepam : A 1,4-benzodiazepinone that is 1,3-dihydro-2H-1,4-benzodiazepin-2-one substituted by a chloro group at position 7, a methyl group at position 1 and a phenyl group at position 5.		2.03101,4-benzodiazepinone;
organochlorine compound		anticonvulsant;
anxiolytic drug;
environmental contaminant;
sedative;
xenobiotic
diclofenac
Diclofenac: A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt.. diclofenac : A monocarboxylic acid consisting of phenylacetic acid having a (2,6-dichlorophenyl)amino group at the 2-position.		3.3811amino acid;
aromatic amine;
dichlorobenzene;
monocarboxylic acid;
secondary amino compound		antipyretic;
drug allergen;
EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor;
environmental contaminant;
non-narcotic analgesic;
non-steroidal anti-inflammatory drug;
xenobiotic
diflunisal
Diflunisal: A salicylate derivative and anti-inflammatory analgesic with actions and side effects similar to those of ASPIRIN.. diflunisal : An organofluorine compound comprising salicylic acid having a 2,4-difluorophenyl group at the 5-position.		2.0310monohydroxybenzoic acid;
organofluorine compound		non-narcotic analgesic;
non-steroidal anti-inflammatory drug
diphenhydramine
Diphenhydramine: A histamine H1 antagonist used as an antiemetic, antitussive, for dermatoses and pruritus, for hypersensitivity reactions, as a hypnotic, an antiparkinson, and as an ingredient in common cold preparations. It has some undesired antimuscarinic and sedative effects.. diphenhydramine : An ether that is the benzhydryl ether of 2-(dimethylamino)ethanol. It is a H1-receptor antagonist used as a antipruritic and antitussive drug.. antitussive : An agent that suppresses cough. Antitussives have a central or a peripheral action on the cough reflex, or a combination of both. Compare with expectorants, which are considered to increase the volume of secretions in the respiratory tract, so facilitating their removal by ciliary action and coughing, and mucolytics, which decrease the viscosity of mucus, facilitating its removal by ciliary action and expectoration.		2.0310ether;
tertiary amino compound		anti-allergic agent;
antidyskinesia agent;
antiemetic;
antiparkinson drug;
antipruritic drug;
antitussive;
H1-receptor antagonist;
local anaesthetic;
muscarinic antagonist;
oneirogen;
sedative
valproic acid
Valproic Acid: A fatty acid with anticonvulsant and anti-manic properties that is used in the treatment of EPILEPSY and BIPOLAR DISORDER. The mechanisms of its therapeutic actions are not well understood. It may act by increasing GAMMA-AMINOBUTYRIC ACID levels in the brain or by altering the properties of VOLTAGE-GATED SODIUM CHANNELS.. valproic acid : A branched-chain saturated fatty acid that comprises of a propyl substituent on a pentanoic acid stem.		2.0310branched-chain fatty acid;
branched-chain saturated fatty acid		anticonvulsant;
antimanic drug;
EC 3.5.1.98 (histone deacetylase) inhibitor;
GABA agent;
neuroprotective agent;
psychotropic drug;
teratogenic agent
domperidone
Domperidone: A specific blocker of dopamine receptors. It speeds gastrointestinal peristalsis, causes prolactin release, and is used as antiemetic and tool in the study of dopaminergic mechanisms.. domperidone : 1-[3-(Piperidin-1-yl)propyl]-1,3-dihydro-2H-benzimidazol-2-one in which the 4-position of the piperidine ring is substituted by a 5-chloro-1,3-dihydro-2H-benzimidazol-2-on-1-yl group. A dopamine antagonist, it is used as an antiemetic for the short-term treatment of nausea and vomiting, and to control gastrointestinal effects of dopaminergic drugs given in the management of parkinsonism. The free base is used in oral suspensions, while the maleate salt is used in tablet preparations.		2.0310benzimidazoles;
heteroarylpiperidine		antiemetic;
dopaminergic antagonist
doxazosin
Doxazosin: A prazosin-related compound that is a selective alpha-1-adrenergic blocker.. doxazosin : A member of the class of quinazolines that is quinazoline substituted by an amino group at position 4, methoxy groups at positions 6 and 7 and a piperazin-1-yl group at position 2 which in turn is substituted by a 2,3-dihydro-1,4-benzodioxin-2-ylcarbonyl group at position 4. An antihypertensive agent, it is used in the treatment of high blood pressure.		2.0310aromatic amine;
benzodioxine;
monocarboxylic acid amide;
N-acylpiperazine;
N-arylpiperazine;
quinazolines		alpha-adrenergic antagonist;
antihyperplasia drug;
antihypertensive agent;
antineoplastic agent;
vasodilator agent
brl 42810
[no description available]		2.03102-aminopurines;
acetate ester		antiviral drug;
prodrug
flucytosine
Flucytosine: A fluorinated cytosine analog that is used as an antifungal agent.. flucytosine : An organofluorine compound that is cytosine that is substituted at position 5 by a fluorine. A prodrug for the antifungal 5-fluorouracil, it is used for the treatment of systemic fungal infections.		2.0310aminopyrimidine;
nucleoside analogue;
organofluorine compound;
pyrimidine antifungal drug;
pyrimidone		prodrug
fluphenazine
[no description available]		2.0310N-alkylpiperazine;
organofluorine compound;
phenothiazines		anticoronaviral agent;
dopaminergic antagonist;
phenothiazine antipsychotic drug
fluorouracil
Fluorouracil: A pyrimidine analog that is an antineoplastic antimetabolite. It interferes with DNA synthesis by blocking the THYMIDYLATE SYNTHETASE conversion of deoxyuridylic acid to thymidylic acid.. 5-fluorouracil : A nucleobase analogue that is uracil in which the hydrogen at position 5 is replaced by fluorine. It is an antineoplastic agent which acts as an antimetabolite - following conversion to the active deoxynucleotide, it inhibits DNA synthesis (by blocking the conversion of deoxyuridylic acid to thymidylic acid by the cellular enzyme thymidylate synthetase) and so slows tumour growth.		7.1510nucleobase analogue;
organofluorine compound		antimetabolite;
antineoplastic agent;
environmental contaminant;
immunosuppressive agent;
radiosensitizing agent;
xenobiotic
flurbiprofen
Flurbiprofen: An anti-inflammatory analgesic and antipyretic of the phenylalkynoic acid series. It has been shown to reduce bone resorption in periodontal disease by inhibiting CARBONIC ANHYDRASE.. flurbiprofen : A monocarboxylic acid that is a 2-fluoro-[1,1'-biphenyl-4-yl] moiety linked to C-2 of propionic acid. A non-steroidal anti-inflammatory, analgesic and antipyretic, it is used as a pre-operative anti-miotic as well as orally for arthritis or dental pain.		1.9710fluorobiphenyl;
monocarboxylic acid		antipyretic;
EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor;
non-narcotic analgesic;
non-steroidal anti-inflammatory drug
gabapentin
Gabapentin: A cyclohexane-gamma-aminobutyric acid derivative that is used for the treatment of PARTIAL SEIZURES; NEURALGIA; and RESTLESS LEGS SYNDROME.. gabapentin : A gamma-amino acid that is cyclohexane substituted at position 1 by aminomethyl and carboxymethyl groups. Used for treatment of neuropathic pain and restless legs syndrome.		2.0310gamma-amino acidanticonvulsant;
calcium channel blocker;
environmental contaminant;
xenobiotic
glimepiride
glimepiride: structure given in first source		2.0310sulfonamide
glipizide
Glipizide: An oral hypoglycemic agent which is rapidly absorbed and completely metabolized.. glipizide : An N-sulfonylurea that is glyburide in which the (5-chloro-2-methoxybenzoyl group is replaced by a (5-methylpyrazin-2-yl)carbonyl group. An oral hypoglycemic agent, it is used in the treatment of type 2 diabetes mellitus.		2.0310aromatic amide;
monocarboxylic acid amide;
N-sulfonylurea;
pyrazines		EC 2.7.1.33 (pantothenate kinase) inhibitor;
hypoglycemic agent;
insulin secretagogue
glyburide
Glyburide: An antidiabetic sulfonylurea derivative with actions like those of chlorpropamide. glyburide : An N-sulfonylurea that is acetohexamide in which the acetyl group is replaced by a 2-(5-chloro-2-methoxybenzamido)ethyl group.		2.0310monochlorobenzenes;
N-sulfonylurea		anti-arrhythmia drug;
EC 2.7.1.33 (pantothenate kinase) inhibitor;
EC 3.6.3.49 (channel-conductance-controlling ATPase) inhibitor;
hypoglycemic agent
granisetron
[no description available]		2.0310aromatic amide;
indazoles
haloperidol
Haloperidol: A phenyl-piperidinyl-butyrophenone that is used primarily to treat SCHIZOPHRENIA and other PSYCHOSES. It is also used in schizoaffective disorder, DELUSIONAL DISORDERS, ballism, and TOURETTE SYNDROME (a drug of choice) and occasionally as adjunctive therapy in INTELLECTUAL DISABILITY and the chorea of HUNTINGTON DISEASE. It is a potent antiemetic and is used in the treatment of intractable HICCUPS. (From AMA Drug Evaluations Annual, 1994, p279). haloperidol : A compound composed of a central piperidine structure with hydroxy and p-chlorophenyl substituents at position 4 and an N-linked p-fluorobutyrophenone moiety.		2.0310aromatic ketone;
hydroxypiperidine;
monochlorobenzenes;
organofluorine compound;
tertiary alcohol		antidyskinesia agent;
antiemetic;
dopaminergic antagonist;
first generation antipsychotic;
serotonergic antagonist
hydrochlorothiazide
Hydrochlorothiazide: A thiazide diuretic often considered the prototypical member of this class. It reduces the reabsorption of electrolytes from the renal tubules. This results in increased excretion of water and electrolytes, including sodium, potassium, chloride, and magnesium. It is used in the treatment of several disorders including edema, hypertension, diabetes insipidus, and hypoparathyroidism.. hydrochlorothiazide : A benzothiadiazine that is 3,4-dihydro-2H-1,2,4-benzothiadiazine 1,1-dioxide substituted by a chloro group at position 6 and a sulfonamide at 7. It is diuretic used for the treatment of hypertension and congestive heart failure.		2.0310benzothiadiazine;
organochlorine compound;
sulfonamide		antihypertensive agent;
diuretic;
environmental contaminant;
xenobiotic
imipramine
Imipramine: The prototypical tricyclic antidepressant. It has been used in major depression, dysthymia, bipolar depression, attention-deficit disorders, agoraphobia, and panic disorders. It has less sedative effect than some other members of this therapeutic group.. imipramine : A dibenzoazepine that is 5H-dibenzo[b,f]azepine substituted by a 3-(dimethylamino)propyl group at the nitrogen atom.		2.0310dibenzoazepineadrenergic uptake inhibitor;
antidepressant;
EC 3.4.21.26 (prolyl oligopeptidase) inhibitor
indomethacin
Indomethacin: A non-steroidal anti-inflammatory agent (NSAID) that inhibits CYCLOOXYGENASE, which is necessary for the formation of PROSTAGLANDINS and other AUTACOIDS. It also inhibits the motility of POLYMORPHONUCLEAR LEUKOCYTES.. indometacin : A member of the class of indole-3-acetic acids that is indole-3-acetic acid in which the indole ring is substituted at positions 1, 2 and 5 by p-chlorobenzoyl, methyl, and methoxy groups, respectively. A non-steroidal anti-inflammatory drug, it is used in the treatment of musculoskeletal and joint disorders including osteoarthritis, rheumatoid arthritis, gout, bursitis and tendinitis.		2.1510aromatic ether;
indole-3-acetic acids;
monochlorobenzenes;
N-acylindole		analgesic;
drug metabolite;
EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor;
environmental contaminant;
gout suppressant;
non-steroidal anti-inflammatory drug;
xenobiotic metabolite;
xenobiotic
avapro
Irbesartan: A spiro compound, biphenyl and tetrazole derivative that acts as an angiotensin II type 1 receptor antagonist. It is used in the management of HYPERTENSION, and in the treatment of kidney disease.. irbesartan : A biphenylyltetrazole that is an angiotensin II receptor antagonist used mainly for the treatment of hypertension.		2.0310azaspiro compound;
biphenylyltetrazole		angiotensin receptor antagonist;
antihypertensive agent;
environmental contaminant;
xenobiotic
isoproterenol
Isoproterenol: Isopropyl analog of EPINEPHRINE; beta-sympathomimetic that acts on the heart, bronchi, skeletal muscle, alimentary tract, etc. It is used mainly as bronchodilator and heart stimulant.. isoprenaline : A secondary amino compound that is noradrenaline in which one of the hydrogens attached to the nitrogen is replaced by an isopropyl group. A sympathomimetic acting almost exclusively on beta-adrenergic receptors, it is used (mainly as the hydrochloride salt) as a bronghodilator and heart stimulant for the management of a variety of cardiac disorders.		1.9610catechols;
secondary alcohol;
secondary amino compound		beta-adrenergic agonist;
bronchodilator agent;
cardiotonic drug;
sympathomimetic agent
itraconazole
[no description available]		2.0310piperazines
lansoprazole
Lansoprazole: A 2,2,2-trifluoroethoxypyridyl derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS. Lansoprazole is a racemic mixture of (R)- and (S)-isomers.		2.0310benzimidazoles;
pyridines;
sulfoxide		anti-ulcer drug;
EC 3.6.3.10 (H(+)/K(+)-exchanging ATPase) inhibitor
letrozole
[no description available]		2.0310nitrile;
triazoles		antineoplastic agent;
EC 1.14.14.14 (aromatase) inhibitor
losartan
Losartan: An antagonist of ANGIOTENSIN TYPE 1 RECEPTOR with antihypertensive activity due to the reduced pressor effect of ANGIOTENSIN II.. losartan : A biphenylyltetrazole where a 1,1'-biphenyl group is attached at the 5-position and has an additional trisubstituted imidazol-1-ylmethyl group at the 4'-position		2.0310biphenylyltetrazole;
imidazoles		angiotensin receptor antagonist;
anti-arrhythmia drug;
antihypertensive agent;
endothelin receptor antagonist
mesalamine
Mesalamine: An anti-inflammatory agent, structurally related to the SALICYLATES, which is active in INFLAMMATORY BOWEL DISEASE. It is considered to be the active moiety of SULPHASALAZINE. (From Martindale, The Extra Pharmacopoeia, 30th ed). mesalamine : A monohydroxybenzoic acid that is salicylic acid substituted by an amino group at the 5-position.		3.7721amino acid;
aromatic amine;
monocarboxylic acid;
monohydroxybenzoic acid;
phenols		non-steroidal anti-inflammatory drug
metoclopramide
Metoclopramide: A dopamine D2 antagonist that is used as an antiemetic.. metoclopramide : A member of the class of benzamides resulting from the formal condensation of 4-amino-5-chloro-2-methoxybenzoic acid with the primary amino group of N,N-diethylethane-1,2-diamine.		2.0310benzamides;
monochlorobenzenes;
substituted aniline;
tertiary amino compound		antiemetic;
dopaminergic antagonist;
environmental contaminant;
gastrointestinal drug;
xenobiotic
metronidazole
Metronidazole: A nitroimidazole used to treat AMEBIASIS; VAGINITIS; TRICHOMONAS INFECTIONS; GIARDIASIS; ANAEROBIC BACTERIA; and TREPONEMAL INFECTIONS.. metronidazole : A member of the class of imidazoles substituted at C-1, -2 and -5 with 2-hydroxyethyl, nitro and methyl groups respectively. It has activity against anaerobic bacteria and protozoa, and has a radiosensitising effect on hypoxic tumour cells. It may be given by mouth in tablets, or as the benzoate in an oral suspension. The hydrochloride salt can be used in intravenous infusions. Metronidazole is a prodrug and is selective for anaerobic bacteria due to their ability to intracellularly reduce the nitro group of metronidazole to give nitroso-containing intermediates. These can covalently bind to DNA, disrupting its helical structure, inducing DNA strand breaks and inhibiting bacterial nucleic acid synthesis, ultimately resulting in bacterial cell death.		1.9610C-nitro compound;
imidazoles;
primary alcohol		antiamoebic agent;
antibacterial drug;
antimicrobial agent;
antiparasitic agent;
antitrichomonal drug;
environmental contaminant;
prodrug;
radiosensitizing agent;
xenobiotic
midazolam
Midazolam: A short-acting hypnotic-sedative drug with anxiolytic and amnestic properties. It is used in dentistry, cardiac surgery, endoscopic procedures, as preanesthetic medication, and as an adjunct to local anesthesia. The short duration and cardiorespiratory stability makes it useful in poor-risk, elderly, and cardiac patients. It is water-soluble at pH less than 4 and lipid-soluble at physiological pH.. midazolam : An imidazobenzodiazepine that is 4H-imidazo[1,5-a][1,4]benzodiazepine which is substituted by a methyl, 2-fluorophenyl and chloro groups at positions 1, 6 and 8, respectively.		2.0310imidazobenzodiazepine;
monofluorobenzenes;
organochlorine compound		anticonvulsant;
antineoplastic agent;
anxiolytic drug;
apoptosis inducer;
central nervous system depressant;
GABAA receptor agonist;
general anaesthetic;
muscle relaxant;
sedative
milrinone
[no description available]		2.0310bipyridines;
nitrile;
pyridone		cardiotonic drug;
EC 3.1.4.17 (3',5'-cyclic-nucleotide phosphodiesterase) inhibitor;
platelet aggregation inhibitor;
vasodilator agent
naratriptan
naratriptan: structure given in first source		2.0310heteroarylpiperidine;
sulfonamide;
tryptamines		serotonergic agonist;
vasoconstrictor agent
nevirapine
Nevirapine: A potent, non-nucleoside reverse transcriptase inhibitor used in combination with nucleoside analogues for treatment of HIV INFECTIONS and AIDS.. nevirapine : A dipyridodiazepine that is 5,11-dihydro-6H-dipyrido[3,2-b:2',3'-e][1,4]diazepine which is substituted by methyl, oxo, and cyclopropyl groups at positions 4, 6, and 11, respectively. A non-nucleoside reverse transcriptase inhibitor with activity against HIV-1, it is used in combination with other antiretrovirals for the treatment of HIV infection.		2.0310cyclopropanes;
dipyridodiazepine		antiviral drug;
HIV-1 reverse transcriptase inhibitor
nifedipine
Nifedipine: A potent vasodilator agent with calcium antagonistic action. It is a useful anti-anginal agent that also lowers blood pressure.		2.0310C-nitro compound;
dihydropyridine;
methyl ester		calcium channel blocker;
human metabolite;
tocolytic agent;
vasodilator agent
nimodipine
Nimodipine: A calcium channel blockader with preferential cerebrovascular activity. It has marked cerebrovascular dilating effects and lowers blood pressure.. nimodipine : A dihydropyridine that is 1,4-dihydropyridine which is substituted by methyl groups at positions 2 and 6, a (2-methoxyethoxy)carbonyl group at position 3, a m-nitrophenyl group at position 4, and an isopropoxycarbonyl group at position 5. An L-type calcium channel blocker, it acts particularly on cerebral circulation, and is used both orally and intravenously for the prevention and treatment of subarachnoid hemorrhage from ruptured intracranial aneurysm.		2.03102-methoxyethyl ester;
C-nitro compound;
dicarboxylic acids and O-substituted derivatives;
diester;
dihydropyridine;
isopropyl ester		antihypertensive agent;
calcium channel blocker;
cardiovascular drug;
vasodilator agent
nitrazepam
Nitrazepam: A benzodiazepine derivative used as an anticonvulsant and hypnotic.. nitrazepam : A 1,4-benzodiazepinone that is 1,3-dihydro-2H-1,4-benzodiazepin-2-one which is substituted at positions 5 and 7 by phenyl and nitro groups, respectively. It is used as a hypnotic for the short-term management of insomnia and for the treatment of epileptic spasms in infants (West's syndrome).		2.03101,4-benzodiazepinone;
C-nitro compound		anticonvulsant;
antispasmodic drug;
drug metabolite;
GABA modulator;
sedative
nizatidine
[no description available]		2.03101,3-thiazoles;
C-nitro compound;
carboxamidine;
organic sulfide;
tertiary amino compound		anti-ulcer drug;
cholinergic drug;
H2-receptor antagonist
pantoprazole
Pantoprazole: 2-pyridinylmethylsulfinylbenzimidazole proton pump inhibitor that is used in the treatment of GASTROESOPHAGEAL REFLUX and PEPTIC ULCER.. pantoprazole : A member of the class of benzimidazoles that is 1H-benzimidazole substituted by a difluoromethoxy group at position 5 and a [(3,4-dimethoxypyridin-2-yl)methyl]sulfinyl group at position 2.		2.0310aromatic ether;
benzimidazoles;
organofluorine compound;
pyridines;
sulfoxide		anti-ulcer drug;
EC 3.6.3.10 (H(+)/K(+)-exchanging ATPase) inhibitor;
environmental contaminant;
xenobiotic
phenobarbital
Phenobarbital: A barbituric acid derivative that acts as a nonselective central nervous system depressant. It potentiates GAMMA-AMINOBUTYRIC ACID action on GABA-A RECEPTORS, and modulates chloride currents through receptor channels. It also inhibits glutamate induced depolarizations.. phenobarbital : A member of the class of barbiturates, the structure of which is that of barbituric acid substituted at C-5 by ethyl and phenyl groups.		2.0310barbituratesanticonvulsant;
drug allergen;
excitatory amino acid antagonist;
sedative
prazosin
Prazosin: A selective adrenergic alpha-1 antagonist used in the treatment of HEART FAILURE; HYPERTENSION; PHEOCHROMOCYTOMA; RAYNAUD DISEASE; PROSTATIC HYPERTROPHY; and URINARY RETENTION.. prazosin : A member of the class of piperazines that is piperazine substituted by a furan-2-ylcarbonyl group and a 4-amino-6,7-dimethoxyquinazolin-2-yl group at positions 1 and 4 respectively.		2.0310aromatic ether;
furans;
monocarboxylic acid amide;
piperazines;
quinazolines		alpha-adrenergic antagonist;
antihypertensive agent;
EC 3.4.21.26 (prolyl oligopeptidase) inhibitor
primidone
Primidone: A barbiturate derivative that acts as a GABA modulator and anti-epileptic agent. It is partly metabolized to PHENOBARBITAL in the body and owes some of its actions to this metabolite.. primidone : A pyrimidone that is dihydropyrimidine-4,6(1H,5H)-dione substituted by an ethyl and a phenyl group at position 5. It is used as an anticonvulsant for treatment of various types of seizures.		2.0310pyrimidoneanticonvulsant;
environmental contaminant;
xenobiotic
procainamide
Procainamide: A class Ia antiarrhythmic drug that is structurally-related to PROCAINE.. procainamide : A benzamide that is 4-aminobenzamide substituted on the amide N by a 2-(diethylamino)ethyl group. It is a pharmaceutical antiarrhythmic agent used for the medical treatment of cardiac arrhythmias.		2.0310benzamidesanti-arrhythmia drug;
platelet aggregation inhibitor;
sodium channel blocker
protriptyline
Protriptyline: Tricyclic antidepressant similar in action and side effects to IMIPRAMINE. It may produce excitation.		2.0310carbotricyclic compoundantidepressant
raloxifene
raloxifene : A member of the class of 1-benzothiophenes that is 1-benzothiophene in which the hydrogens at positions 2, 3, and 6 have been replaced by p-hydroxyphenyl, p-[2-(piperidin-1-yl)ethoxy]benzoyl, and hydroxy groups, respectively.		2.03101-benzothiophenes;
aromatic ketone;
N-oxyethylpiperidine;
phenols		bone density conservation agent;
estrogen antagonist;
estrogen receptor modulator
risperidone
Risperidone: A selective blocker of DOPAMINE D2 RECEPTORS and SEROTONIN 5-HT2 RECEPTORS that acts as an atypical antipsychotic agent. It has been shown to improve both positive and negative symptoms in the treatment of SCHIZOPHRENIA.. risperidone : A member of the class of pyridopyrimidines that is 2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one carrying an additional 2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl group at position 2.		2.03101,2-benzoxazoles;
heteroarylpiperidine;
organofluorine compound;
pyridopyrimidine		alpha-adrenergic antagonist;
dopaminergic antagonist;
EC 3.4.21.26 (prolyl oligopeptidase) inhibitor;
H1-receptor antagonist;
psychotropic drug;
second generation antipsychotic;
serotonergic antagonist
rizatriptan
rizatriptan: structure given in first source; RN given refers to benzoate		2.0310tryptaminesanti-inflammatory drug;
serotonergic agonist;
vasoconstrictor agent
rofecoxib
[no description available]		2.0310butenolide;
sulfone		analgesic;
cyclooxygenase 2 inhibitor;
non-steroidal anti-inflammatory drug
ropinirole
[no description available]		2.0310indolones;
tertiary amine		antidyskinesia agent;
antiparkinson drug;
central nervous system drug;
dopamine agonist
saccharin
Saccharin: Flavoring agent and non-nutritive sweetener.. saccharin : A 1,2-benzisothiazole having a keto-group at the 3-position and two oxo substituents at the 1-position. It is used as an artificial sweetening agent.		2.03101,2-benzisothiazole;
N-sulfonylcarboxamide		environmental contaminant;
sweetening agent;
xenobiotic
sulfasalazine
Sulfasalazine: A drug that is used in the management of inflammatory bowel diseases. Its activity is generally considered to lie in its metabolic breakdown product, 5-aminosalicylic acid (see MESALAMINE) released in the colon. (From Martindale, The Extra Pharmacopoeia, 30th ed, p907). sulfasalazine : An azobenzene consisting of diphenyldiazene having a carboxy substituent at the 4-position, a hydroxy substituent at the 3-position and a 2-pyridylaminosulphonyl substituent at the 4'-position.		2.1510
telenzepine
telenzepine: structure given in first source		2.0310benzodiazepine
tolbutamide
Tolbutamide: A sulphonylurea hypoglycemic agent with actions and uses similar to those of CHLORPROPAMIDE. (From Martindale, The Extra Pharmacopoeia, 30th ed, p290). tolbutamide : An N-sulfonylurea that consists of 1-butylurea having a tosyl group attached at the 3-position.		2.0310N-sulfonylureahuman metabolite;
hypoglycemic agent;
insulin secretagogue;
potassium channel blocker
tolmetin
Tolmetin: A non-steroidal anti-inflammatory agent (ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL) similar in mode of action to INDOMETHACIN.. tolmetin : A monocarboxylic acid that is (1-methylpyrrol-2-yl)acetic acid substituted at position 5 on the pyrrole ring by a 4-methylbenzoyl group. Used in the form of its sodium salt dihydrate as a nonselective nonsteroidal anti-inflammatory drug.		3.3511aromatic ketone;
monocarboxylic acid;
pyrroles		EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor;
non-steroidal anti-inflammatory drug
ultram
2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol : A tertiary alcohol that is cyclohexanol substituted at positions 1 and 2 by 3-methoxyphenyl and dimethylaminomethyl groups respectively.		2.0310aromatic ether;
tertiary alcohol;
tertiary amino compound
triamterene
Triamterene: A pteridinetriamine compound that inhibits SODIUM reabsorption through SODIUM CHANNELS in renal EPITHELIAL CELLS.. triamterene : Pteridine substituted at positions 2, 4 and 7 with amino groups and at position 6 with a phenyl group. A sodium channel blocker, it is used as a diuretic in the treatment of hypertension and oedema.		2.0310pteridinesdiuretic;
sodium channel blocker
triazolam
Triazolam: A short-acting benzodiazepine used in the treatment of insomnia. Some countries temporarily withdrew triazolam from the market because of concerns about adverse reactions, mostly psychological, associated with higher dose ranges. Its use at lower doses with appropriate care and labeling has been reaffirmed by the FDA and most other countries.		2.0310triazolobenzodiazepinesedative
trimethoprim
Trimethoprim: A pyrimidine inhibitor of dihydrofolate reductase, it is an antibacterial related to PYRIMETHAMINE. It is potentiated by SULFONAMIDES and the TRIMETHOPRIM, SULFAMETHOXAZOLE DRUG COMBINATION is the form most often used. It is sometimes used alone as an antimalarial. TRIMETHOPRIM RESISTANCE has been reported.. trimethoprim : An aminopyrimidine antibiotic whose structure consists of pyrimidine 2,4-diamine and 1,2,3-trimethoxybenzene moieties linked by a methylene bridge.		2.0310aminopyrimidine;
methoxybenzenes		antibacterial drug;
diuretic;
drug allergen;
EC 1.5.1.3 (dihydrofolate reductase) inhibitor;
environmental contaminant;
xenobiotic
delavirdine
Delavirdine: A potent, non-nucleoside reverse transcriptase inhibitor with activity specific for HIV-1.. delavirdine : The amide resulting from the formal condensation of 5-[(methylsulfonyl)amino]-1H-indole-2-carboxylic acid and 4-amino group of 1-[3-(isopropylamino)pyridin-2-yl]piperazine, delavirdine is a non-nucleoside reverse transcriptase inhibitor with activity specific for HIV-1. Viral resistance emerges rapidly when delavirdine is used alone, so it is therefore used (as the methanesulfonic acid salt) with other antiretrovirals for combination therapy of HIV infection.		2.0310aminopyridine;
indolecarboxamide;
N-acylpiperazine;
sulfonamide		antiviral drug;
HIV-1 reverse transcriptase inhibitor
zaleplon
zaleplon: an azabicyclo(4.3.0)nonane; a nonbenzodiazepine; one of the so-called of Z drugs (zopiclone, eszopiclone, zolpidem, and zaleplon) for which there is some correlation with tumors; a hypnotic with less marked effect on psychomotor functions compared to lorazepam. zaleplon : A pyrazolo[1,5-a]pyrimidine having a nitrile group at position 3 and a 3-(N-ethylacetamido)phenyl substituent at the 7-position.		2.0310nitrile;
pyrazolopyrimidine		anticonvulsant;
anxiolytic drug;
central nervous system depressant;
sedative
zinc chloride
zinc chloride: RN given refers to parent cpd. zinc dichloride : A compound of zinc and chloride ions in the ratio 1:2. It exists in four crystalline forms, in each of which the Zn(2+) ions are trigonal planar coordinated to four chloride ions.		1.9910inorganic chloride;
zinc molecular entity		astringent;
disinfectant;
EC 5.3.3.5 (cholestenol Delta-isomerase) inhibitor;
Lewis acid
zolpidem
Zolpidem: An imidazopyridine derivative and short-acting GABA-A receptor agonist that is used for the treatment of INSOMNIA.. zolpidem : An imidazo[1,2-a]pyridine compound having a 4-tolyl group at the 2-position, an N,N-dimethylcarbamoylmethyl group at the 3-position and a methyl substituent at the 6-position.		2.0310imidazopyridinecentral nervous system depressant;
GABA agonist;
sedative
hydrocortisone acetate
hydrocortisone acetate: RN given refers to cpd without isomeric designation		4.0431cortisol ester;
tertiary alpha-hydroxy ketone
cortisone acetate
Cortisone Acetate: The acetate ester of cortisone that is used mainly for replacement therapy in adrenocortical insufficiency and in the treatment of many allergic and inflammatory disorders.		1.9610corticosteroid hormone
corticosterone
[no description available]		2.673011beta-hydroxy steroid;
20-oxo steroid;
21-hydroxy steroid;
3-oxo-Delta(4) steroid;
C21-steroid;
glucocorticoid;
primary alpha-hydroxy ketone		human metabolite;
mouse metabolite
prednisolone
Prednisolone: A glucocorticoid with the general properties of the corticosteroids. It is the drug of choice for all conditions in which routine systemic corticosteroid therapy is indicated, except adrenal deficiency states.. prednisolone : A glucocorticoid that is prednisone in which the oxo group at position 11 has been reduced to the corresponding beta-hydroxy group. It is a drug metabolite of prednisone.		151122311beta-hydroxy steroid;
17alpha-hydroxy steroid;
20-oxo steroid;
21-hydroxy steroid;
3-oxo-Delta(1),Delta(4)-steroid;
C21-steroid;
glucocorticoid;
primary alpha-hydroxy ketone;
tertiary alpha-hydroxy ketone		adrenergic agent;
anti-inflammatory drug;
antineoplastic agent;
drug metabolite;
environmental contaminant;
immunosuppressive agent;
xenobiotic
spironolactone
Spironolactone: A potassium sparing diuretic that acts by antagonism of aldosterone in the distal renal tubules. It is used mainly in the treatment of refractory edema in patients with congestive heart failure, nephrotic syndrome, or hepatic cirrhosis. Its effects on the endocrine system are utilized in the treatments of hirsutism and acne but they can lead to adverse effects. (From Martindale, The Extra Pharmacopoeia, 30th ed, p827). spironolactone : A steroid lactone that is 17alpha-pregn-4-ene-21,17-carbolactone substituted by an oxo group at position 3 and an alpha-acetylsulfanyl group at position 7.		2.03103-oxo-Delta(4) steroid;
oxaspiro compound;
steroid lactone;
thioester		aldosterone antagonist;
antihypertensive agent;
diuretic;
environmental contaminant;
xenobiotic
prednisolone acetate
prednisolone acetate: RN given refers to cpd with locant for acetate group in position 21 & (11 beta)-isomer		4.79100corticosteroid hormone
prednisone
Prednisone: A synthetic anti-inflammatory glucocorticoid derived from CORTISONE. It is biologically inert and converted to PREDNISOLONE in the liver.. prednisone : A synthetic glucocorticoid drug that is particularly effective as an immunosuppressant, and affects virtually all of the immune system. Prednisone is a prodrug that is converted by the liver into prednisolone (a beta-hydroxy group instead of the oxo group at position 11), which is the active drug and also a steroid.		2.894011-oxo steroid;
17alpha-hydroxy steroid;
20-oxo steroid;
21-hydroxy steroid;
3-oxo-Delta(1),Delta(4)-steroid;
C21-steroid;
glucocorticoid;
primary alpha-hydroxy ketone;
tertiary alpha-hydroxy ketone		adrenergic agent;
anti-inflammatory drug;
antineoplastic agent;
immunosuppressive agent;
prodrug
paramethasone
Paramethasone: A glucocorticoid with the general properties of corticosteroids. It has been used by mouth in the treatment of all conditions in which corticosteroid therapy is indicated except adrenal-deficiency states for which its lack of sodium-retaining properties makes it less suitable than HYDROCORTISONE with supplementary FLUDROCORTISONE. (From Martindale, The Extra Pharmacopoeia, 30th ed, p737)		2.3720fluorinated steroid
fluprednisolone
Fluprednisolone: A synthetic glucocorticoid with anti-inflammatory properties.		2.3720fluorinated steroid
methylprednisolone acetate
Methylprednisolone Acetate: Methylprednisolone derivative that is used as an anti-inflammatory agent for the treatment of ALLERGY and ALLERGIC RHINITIS; ASTHMA; and BURSITIS; and for the treatment of ADRENAL INSUFFICIENCY.. methylprednisolone acetate : An acetate ester resulting from the formal condensation of the 21-hydroxy function of 6alpha-methylprednisolone compound with acetic acid.		1.931011beta-hydroxy steroid;
17alpha-hydroxy steroid;
20-oxo steroid;
3-oxo-Delta(1),Delta(4)-steroid;
acetate ester;
glucocorticoid;
steroid ester;
tertiary alpha-hydroxy ketone		anti-inflammatory drug
penicillin g
Penicillin G: A penicillin derivative commonly used in the form of its sodium or potassium salts in the treatment of a variety of infections. It is effective against most gram-positive bacteria and against gram-negative cocci. It has also been used as an experimental convulsant because of its actions on GAMMA-AMINOBUTYRIC ACID mediated synaptic transmission.. benzylpenicillin : A penicillin in which the substituent at position 6 of the penam ring is a phenylacetamido group.		2.0310penicillin allergen;
penicillin		antibacterial drug;
drug allergen;
epitope
biguanides
Biguanides: Derivatives of biguanide (the structure formula HN(C(NH)NH2)2) that are primarily used as oral HYPOGLYCEMIC AGENTS for the treatment of DIABETES MELLITUS, TYPE 2 and PREDIABETES.. biguanides : A class of oral hypoglycemic drugs used for diabetes mellitus or prediabetes treatment. They have a structure based on the 2-carbamimidoylguanidine skeleton.		210guanidines
alanine
Alanine: A non-essential amino acid that occurs in high levels in its free state in plasma. It is produced from pyruvate by transamination. It is involved in sugar and acid metabolism, increases IMMUNITY, and provides energy for muscle tissue, BRAIN, and the CENTRAL NERVOUS SYSTEM.. alanine : An alpha-amino acid that consists of propionic acid bearing an amino substituent at position 2.		2.1710alanine zwitterion;
alanine;
L-alpha-amino acid;
proteinogenic amino acid;
pyruvate family amino acid		EC 4.3.1.15 (diaminopropionate ammonia-lyase) inhibitor;
fundamental metabolite
chloramphenicol
Amphenicol: Chloramphenicol and its derivatives.		2.0310C-nitro compound;
carboxamide;
diol;
organochlorine compound		antibacterial drug;
antimicrobial agent;
Escherichia coli metabolite;
geroprotector;
Mycoplasma genitalium metabolite;
protein synthesis inhibitor
physostigmine
Physostigmine: A cholinesterase inhibitor that is rapidly absorbed through membranes. It can be applied topically to the conjunctiva. It also can cross the blood-brain barrier and is used when central nervous system effects are desired, as in the treatment of severe anticholinergic toxicity.		2.0310carbamate ester;
indole alkaloid		antidote to curare poisoning;
EC 3.1.1.8 (cholinesterase) inhibitor;
miotic
sucrose
Saccharum: A plant genus of the family POACEAE widely cultivated in the tropics for the sweet cane that is processed into sugar.		2.0710glycosyl glycosidealgal metabolite;
Escherichia coli metabolite;
human metabolite;
mouse metabolite;
osmolyte;
Saccharomyces cerevisiae metabolite;
sweetening agent
ethinyl estradiol
Ethinyl Estradiol: A semisynthetic alkylated ESTRADIOL with a 17-alpha-ethinyl substitution. It has high estrogenic potency when administered orally, and is often used as the estrogenic component in ORAL CONTRACEPTIVES.. 17alpha-ethynylestradiol : A 3-hydroxy steroid that is estradiol substituted by a ethynyl group at position 17. It is a xenoestrogen synthesized from estradiol and has been shown to exhibit high estrogenic potency on oral administration.		2.392017-hydroxy steroid;
3-hydroxy steroid;
terminal acetylenic compound		xenoestrogen
cloxacillin
Cloxacillin: A semi-synthetic antibiotic that is a chlorinated derivative of OXACILLIN.. cloxacillin : A semisynthetic penicillin antibiotic carrying a 3-(2-chlorophenyl)-5-methylisoxazole-4-carboxamido group at position 6.		2.0310penicillin allergen;
penicillin;
semisynthetic derivative		antibacterial agent;
antibacterial drug
1,2-dipalmitoylphosphatidylcholine
1,2-Dipalmitoylphosphatidylcholine: Synthetic phospholipid used in liposomes and lipid bilayers to study biological membranes. It is also a major constituent of PULMONARY SURFACTANTS.		2.4820
egtazic acid
Egtazic Acid: A chelating agent relatively more specific for calcium and less toxic than EDETIC ACID.. ethylene glycol bis(2-aminoethyl)tetraacetic acid : A diether that is ethylene glycol in which the hydrogens of the hydroxy groups have been replaced by 2-[bis(carboxymethyl)amino]ethyl group respectively.		1.9910diether;
tertiary amino compound;
tetracarboxylic acid		chelator
fluocinolone acetonide
Fluocinolone Acetonide: A glucocorticoid derivative used topically in the treatment of various skin disorders. It is usually employed as a cream, gel, lotion, or ointment. It has also been used topically in the treatment of inflammatory eye, ear, and nose disorders. (From Martindale, The Extra Pharmacopoeia, 30th ed, p732). fluocinolone acetonide : A fluorinated steroid that is flunisolide in which the hydrogen at position 9 is replaced by fluorine. A corticosteroid with glucocorticoid activity, it is used (both as the anhydrous form and as the dihydrate) in creams, gels and ointments for the treatment of various skin disorders.		2.372011beta-hydroxy steroid;
20-oxo steroid;
21-hydroxy steroid;
3-oxo-Delta(1),Delta(4)-steroid;
cyclic ketal;
fluorinated steroid;
glucocorticoid;
organic heteropentacyclic compound;
primary alpha-hydroxy ketone		anti-inflammatory drug;
antipruritic drug
norethindrone
Norethindrone: A synthetic progestational hormone with actions similar to those of PROGESTERONE but functioning as a more potent inhibitor of ovulation. It has weak estrogenic and androgenic properties. The hormone has been used in treating amenorrhea, functional uterine bleeding, endometriosis, and for CONTRACEPTION.. norethisterone : A 17beta-hydroxy steroid that is testosterone in which the hydrogen at position 17 is replaced by an ethynyl group and in which the methyl group attached to position 10 is replaced by hydrogen.		2.031017beta-hydroxy steroid;
3-oxo-Delta(4) steroid;
terminal acetylenic compound;
tertiary alcohol		progestin;
synthetic oral contraceptive
cytarabine
[no description available]		3.3611beta-D-arabinoside;
monosaccharide derivative;
pyrimidine nucleoside		antimetabolite;
antineoplastic agent;
antiviral agent;
immunosuppressive agent
trifluridine
Trifluridine: An antiviral derivative of THYMIDINE used mainly in the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to HERPES SIMPLEX virus. (From Martindale, The Extra Pharmacopoeia, 30th ed, p557). trifluridine : A pyrimidine 2'-deoxyribonucleoside compound having 5-trifluoromethyluracil as the nucleobase. An antiviral drug used mainly in the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis.		6.1531nucleoside analogue;
organofluorine compound;
pyrimidine 2'-deoxyribonucleoside		antimetabolite;
antineoplastic agent;
antiviral drug;
EC 2.1.1.45 (thymidylate synthase) inhibitor
medroxyprogesterone acetate
[no description available]		2.021020-oxo steroid;
3-oxo-Delta(4) steroid;
acetate ester;
corticosteroid;
steroid ester		adjuvant;
androgen;
antineoplastic agent;
antioxidant;
female contraceptive drug;
inhibitor;
progestin;
synthetic oral contraceptive
triamcinolone acetonide
Triamcinolone Acetonide: An esterified form of TRIAMCINOLONE. It is an anti-inflammatory glucocorticoid used topically in the treatment of various skin disorders. Intralesional, intramuscular, and intra-articular injections are also administered under certain conditions.. triamcinolone acetonide : A synthetic glucocorticoid that is the 16,17-acetonide of triamcinolone. Used to treat various skin infections.		2.653011beta-hydroxy steroid;
20-oxo steroid;
21-hydroxy steroid;
3-oxo-Delta(4) steroid;
cyclic ketal;
fluorinated steroid;
glucocorticoid;
primary alpha-hydroxy ketone		anti-allergic agent;
anti-inflammatory drug
phencyclidine
Phencyclidine: A hallucinogen formerly used as a veterinary anesthetic, and briefly as a general anesthetic for humans. Phencyclidine is similar to KETAMINE in structure and in many of its effects. Like ketamine, it can produce a dissociative state. It exerts its pharmacological action through inhibition of NMDA receptors (RECEPTORS, N-METHYL-D-ASPARTATE). As a drug of abuse, it is known as PCP and Angel Dust.. phencyclidine : A member of the class of piperidines that is piperidine in which the nitrogen is substituted with a 1-phenylcyclohexyl group. Formerly used as an anaesthetic agent, it exhibits both hallucinogenic and neurotoxic effects.		2.0310benzenes;
piperidines		anaesthetic;
neurotoxin;
NMDA receptor antagonist;
psychotropic drug
methylprednisolone
Methylprednisolone: A PREDNISOLONE derivative with similar anti-inflammatory action.. 6alpha-methylprednisolone : The 6alpha-stereoisomer of 6-methylprednisolone.		3.23606-methylprednisolone;
primary alpha-hydroxy ketone;
tertiary alpha-hydroxy ketone		adrenergic agent;
anti-inflammatory drug;
antiemetic;
environmental contaminant;
neuroprotective agent;
xenobiotic
trehalose
alpha,alpha-trehalose : A trehalose in which both glucose residues have alpha-configuration at the anomeric carbon.		2.5220trehaloseEscherichia coli metabolite;
geroprotector;
human metabolite;
mouse metabolite;
Saccharomyces cerevisiae metabolite
pyrroles
1H-pyrrole : A tautomer of pyrrole that has the double bonds at positions 2 and 4.. pyrrole : A five-membered monocyclic heteroarene comprising one NH and four CH units which forms the parent compound of the pyrrole group of compounds. Its five-membered ring structure has three tautomers. A 'closed class'.. azole : Any monocyclic heteroarene consisting of a five-membered ring containing nitrogen. Azoles can also contain one or more other non-carbon atoms, such as nitrogen, sulfur or oxygen.		3.3511pyrrole;
secondary amine
tetrahydrofuran
oxolane : A cyclic ether that is butane in which one hydrogen from each methyl group is substituted by an oxygen.		2.0810cyclic ether;
oxolanes;
saturated organic heteromonocyclic parent;
volatile organic compound		polar aprotic solvent
fluocortolone
Fluocortolone: A glucocorticoid with anti-inflammatory activity used topically for various skin disorders.		2.673021-hydroxy steroid
thiazoles
[no description available]		1.99101,3-thiazoles;
mancude organic heteromonocyclic parent;
monocyclic heteroarene
dexamethasone 21-phosphate
dexamethasone 21-phosphate: has anti-inflammatory activity. dexamethasone phosphate : A steroid phosphate that is the 21-O-phospho derivative of dexamethasone.		4.465111beta-hydroxy steroid;
17-hydroxy steroid;
3-oxo-Delta(4) steroid;
fluorinated steroid;
steroid phosphate;
tertiary alpha-hydroxy ketone		glucocorticoid receptor agonist
fluocinonide
Fluocinonide: A topical glucocorticoid used in the treatment of ECZEMA.		2.3720organic molecular entity
betamethasone
Betamethasone: A glucocorticoid given orally, parenterally, by local injection, by inhalation, or applied topically in the management of various disorders in which corticosteroids are indicated. Its lack of mineralocorticoid properties makes betamethasone particularly suitable for treating cerebral edema and congenital adrenal hyperplasia. (From Martindale, The Extra Pharmacopoeia, 30th ed, p724)		4.824211beta-hydroxy steroid;
17alpha-hydroxy steroid;
20-oxo steroid;
21-hydroxy steroid;
3-oxo-Delta(1),Delta(4)-steroid;
fluorinated steroid;
glucocorticoid;
primary alpha-hydroxy ketone;
tertiary alpha-hydroxy ketone		anti-asthmatic agent;
anti-inflammatory drug;
immunosuppressive agent
fluorometholone
Fluorometholone: A glucocorticoid employed, usually as eye drops, in the treatment of allergic and inflammatory conditions of the eye. It has also been used topically in the treatment of various skin disorders. (From Martindale, The Extra Pharmacopoeia, 30th ed, p732). fluorometholone : A member of the class of glucocorticoids that is Delta(1)-progesterone substituted at positions 11beta and 17 by hydroxy groups, at position 6alpha by a methyl group and at position 9 by a fluoro group. Used for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.		2.051011beta-hydroxy steroid;
17alpha-hydroxy steroid;
20-oxo steroid;
3-oxo-Delta(1),Delta(4)-steroid;
fluorinated steroid;
glucocorticoid;
tertiary alpha-hydroxy ketone		anti-inflammatory drug
glycochenodeoxycholic acid
Glycochenodeoxycholic Acid: A bile salt formed in the liver from chenodeoxycholate and glycine, usually as the sodium salt. It acts as a detergent to solubilize fats for absorption and is itself absorbed. It is a cholagogue and choleretic.. glycochenodeoxycholate : A N-acylglycinate that is the conjugate base of glycochenodeoxycholic acid.. glycochenodeoxycholic acid : A bile acid glycine conjugate having 3alpha,7alpha-dihydroxy-5beta-cholan-24-oyl as the bile acid component.		1.9610bile acid glycine conjugatehuman metabolite
erythromycin
Erythromycin: A bacteriostatic antibiotic macrolide produced by Streptomyces erythreus. Erythromycin A is considered its major active component. In sensitive organisms, it inhibits protein synthesis by binding to 50S ribosomal subunits. This binding process inhibits peptidyl transferase activity and interferes with translocation of amino acids during translation and assembly of proteins.. erythromycin : Any of several wide-spectrum macrolide antibiotics obtained from actinomycete Saccharopolyspora erythraea (formerly known as Streptomyces erythraeus).. erythromycin A : An erythromycin that consists of erythronolide A having 2,6-dideoxy-3-C-methyl-3-O-methyl-alpha-L-ribo-hexopyranosyl and 3,4,6-trideoxy-3-(dimethylamino)-beta-D-xylo-hexopyranosyl residues attahced at positions 4 and 6 respectively.		2.4520cyclic ketone;
erythromycin
levonorgestrel
Levonorgestrel: A synthetic progestational hormone with actions similar to those of PROGESTERONE and about twice as potent as its racemic or (+-)-isomer (NORGESTREL). It is used for contraception, control of menstrual disorders, and treatment of endometriosis.		2.031017beta-hydroxy steroid;
3-oxo-Delta(4) steroid;
terminal acetylenic compound		contraceptive drug;
female contraceptive drug;
progestin;
synthetic oral contraceptive
estradiol valerate
[no description available]		2.0310steroid ester
ethambutol
Ethambutol: An antitubercular agent that inhibits the transfer of mycolic acids into the cell wall of the tubercle bacillus. It may also inhibit the synthesis of spermidine in mycobacteria. The action is usually bactericidal, and the drug can penetrate human cell membranes to exert its lethal effect. (From Smith and Reynard, Textbook of Pharmacology, 1992, p863). ethambutol : An ethylenediamine derivative that is ethane-1,2-diamine in which one hydrogen attached to each of the nitrogens is sutstituted by a 1-hydroxybutan-2-yl group (S,S-configuration). It is a bacteriostatic antimycobacterial drug, effective against Mycobacterium tuberculosis and some other mycobacteria. It is used (as the dihydrochloride salt) in combination with other antituberculous drugs in the treatment of pulmonary and extrapulmonary tuberculosis; resistant strains of M. tuberculosis are readily produced if ethambutol is used alone.		2.0310ethanolamines;
ethylenediamine derivative		antitubercular agent;
environmental contaminant;
xenobiotic
sodium hydroxide
Sodium Hydroxide: A highly caustic substance that is used to neutralize acids and make sodium salts. (From Merck Index, 11th ed)		1.9710alkali metal hydroxide
flurandrenolone
Flurandrenolone: A corticosteroid used topically in the treatment of various skin disorders. It is usually employed as a cream or an ointment, and is also used as a polyethylene tape with an adhesive. (From Martindale, The Extra Pharmacopoeia, 30th ed, p733)		2.372021-hydroxy steroid
dronabinol
Dronabinol: A psychoactive compound extracted from the resin of Cannabis sativa (marihuana, hashish). The isomer delta-9-tetrahydrocannabinol (THC) is considered the most active form, producing characteristic mood and perceptual changes associated with this compound.. Delta(9)-tetrahydrocannabinol : A diterpenoid that is 6a,7,8,10a-tetrahydro-6H-benzo[c]chromene substituted at position 1 by a hydroxy group, positions 6, 6 and 9 by methyl groups and at position 3 by a pentyl group. The principal psychoactive constituent of the cannabis plant, it is used for treatment of anorexia associated with AIDS as well as nausea and vomiting associated with cancer chemotherapy.		2.0310benzochromene;
diterpenoid;
phytocannabinoid;
polyketide		cannabinoid receptor agonist;
epitope;
hallucinogen;
metabolite;
non-narcotic analgesic
pimozide
Pimozide: A diphenylbutylpiperidine that is effective as an antipsychotic agent and as an alternative to HALOPERIDOL for the suppression of vocal and motor tics in patients with Tourette syndrome. Although the precise mechanism of action is unknown, blockade of postsynaptic dopamine receptors has been postulated. (From AMA Drug Evaluations Annual, 1994, p403). pimozide : A member of the class of benzimidazoles that is 1,3-dihydro-2H-benzimidazol-2-one in which one of the nitrogens is substituted by a piperidin-4-yl group, which in turn is substituted on the nitrogen by a 4,4-bis(p-fluorophenyl)butyl group.		2.0310benzimidazoles;
heteroarylpiperidine;
organofluorine compound		antidyskinesia agent;
dopaminergic antagonist;
first generation antipsychotic;
H1-receptor antagonist;
serotonergic antagonist
flumethasone
Flumethasone: An anti-inflammatory glucocorticoid used in veterinary practice.		1.961011beta-hydroxy steroid;
17alpha-hydroxy steroid;
20-oxo steroid;
21-hydroxy steroid;
3-oxo-Delta(1),Delta(4)-steroid;
fluorinated steroid;
glucocorticoid;
primary alpha-hydroxy ketone;
tertiary alpha-hydroxy ketone		anti-inflammatory drug
betamethasone valerate
Betamethasone Valerate: The 17-valerate derivative of BETAMETHASONE. It has substantial topical anti-inflammatory activity and relatively low systemic anti-inflammatory activity.. betamethasone valerate : A steroid ester that is betamethasone in which the hydroxy group at the 17alpha position has been converted to the corresponding pentanoate ester.		2.372011beta-hydroxy steroid;
20-oxo steroid;
21-hydroxy steroid;
3-oxo-Delta(1),Delta(4)-steroid;
fluorinated steroid;
primary alpha-hydroxy ketone;
steroid ester		anti-inflammatory drug
methylprednisolone hemisuccinate
Methylprednisolone Hemisuccinate: A water-soluble ester of METHYLPREDNISOLONE used for cardiac, allergic, and hypoxic emergencies.		1.9610corticosteroid hormone;
hemisuccinate
stavudine
Stavudine: A dideoxynucleoside analog that inhibits reverse transcriptase and has in vitro activity against HIV.. stavudine : A nucleoside analogue obtained by formal dehydration across positions 2 and 3 of thymidine. An inhibitor of HIV-1 reverse transcriptase		2.0310dihydrofuran;
nucleoside analogue;
organic molecular entity		antimetabolite;
antiviral agent;
EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor
vantocil
polihexanide: RN given refers to parent cpd		210
floxacillin
Floxacillin: Antibiotic analog of CLOXACILLIN.. flucloxacillin : A penicillin compound having a 6beta-[3-(2-chloro-6-fluorophenyl)-5-methyl-1,2-oxazole-4-carboxamido] side-chain.		2.0310penicillin allergen;
penicillin		antibacterial drug
beclomethasone dipropionate
beclomethasone dipropionate : A steroid ester comprising beclomethasone having propionyl groups at the 17- and 21-positions.		2.372011beta-hydroxy steroid;
20-oxo steroid;
3-oxo-Delta(1),Delta(4)-steroid;
chlorinated steroid;
corticosteroid;
enone;
glucocorticoid;
propanoate ester;
steroid ester		anti-arrhythmia drug;
anti-asthmatic drug;
anti-inflammatory drug;
prodrug
betamethasone-17,21-dipropionate
[no description available]		2.372011beta-hydroxy steroid;
20-oxo steroid;
3-oxo-Delta(1),Delta(4)-steroid;
fluorinated steroid;
propanoate ester;
steroid ester		antipsoriatic
levomethadone
levomethadone : A 6-(dimethylamino)-4,4-diphenylheptan-3-one that has (R)-configuration. It is the active enantiomer of methadone and its hydrochloride salt is used to treat adults who are addicted to drugs such as heroin and morphine.		2.03106-(dimethylamino)-4,4-diphenylheptan-3-oneantitussive;
mu-opioid receptor agonist;
NMDA receptor antagonist;
opioid analgesic
phenylethylmalonamide
Phenylethylmalonamide: A metabolite of primidone.		2.0310amine
gadolinium
Gadolinium: An element of the rare earth family of metals. It has the atomic symbol Gd, atomic number 64, and atomic weight 157.25. Its oxide is used in the control rods of some nuclear reactors.		2.0710f-block element atom;
lanthanoid atom
ethinyl estradiol-norgestrel combination
Ethinyl Estradiol-Norgestrel Combination: ETHINYL ESTRADIOL and NORGESTREL given in fixed proportions.		1.9610
clodronic acid
Clodronic Acid: A diphosphonate which affects calcium metabolism. It inhibits bone resorption and soft tissue calcification.. clodronic acid : An organochlorine compound that is methylene chloride in which both hydrogens are replaced by phosphonic acid groups. It inhibits bone resorption and soft tissue calcification, and is used (often as the disodium salt tetrahydrate) as an adjunct in the treatment of severe hypercalcaemia associated with malignancy, and in the management of osteolytic lesions and bone pain associated with skeletal metastases.		2.04101,1-bis(phosphonic acid);
one-carbon compound;
organochlorine compound		antineoplastic agent;
bone density conservation agent
hydrocortisone-17-butyrate
cortisol 17-butyrate : Cortisol esterified with butyric acid at the 17-hydroxy group.		2.3720butyrate ester;
cortisol ester;
primary alpha-hydroxy ketone		dermatologic drug;
drug allergen
metopimazine
metopimazine: RN given refers to parent cpd; structure		2.0310phenothiazines
cephalexin
Cephalexin: A semisynthetic cephalosporin antibiotic with antimicrobial activity similar to that of CEPHALORIDINE or CEPHALOTHIN, but somewhat less potent. It is effective against both gram-positive and gram-negative organisms.. cephalexin : A semisynthetic first-generation cephalosporin antibiotic having methyl and beta-(2R)-2-amino-2-phenylacetamido groups at the 3- and 7- of the cephem skeleton, respectively. It is effective against both Gram-negative and Gram-positive organisms, and is used for treatment of infections of the skin, respiratory tract and urinary tract.		2.0310beta-lactam antibiotic allergen;
cephalosporin;
semisynthetic derivative		antibacterial drug
metergoline
Metergoline: A dopamine agonist and serotonin antagonist. It has been used similarly to BROMOCRIPTINE as a dopamine agonist and also for MIGRAINE DISORDERS therapy.. metergoline : An ergoline alkaloid that is the N-benzyloxycarbonyl derivative of lysergamine. A 5-HT2 antagonist. Also 5-HT1 antagonist and 5-HT1D ligand. Has moderate affinity for 5-HT6 and high affinity for 5-HT7.		2.0310carbamate ester;
ergoline alkaloid		dopamine agonist;
geroprotector;
serotonergic antagonist
bromocriptine
Bromocriptine: A semisynthetic ergotamine alkaloid that is a dopamine D2 agonist. It suppresses prolactin secretion.		2.0310indole alkaloidantidyskinesia agent;
antiparkinson drug;
dopamine agonist;
hormone antagonist
triamcinolone
Triamcinolone: A glucocorticoid given, as the free alcohol or in esterified form, orally, intramuscularly, by local injection, by inhalation, or applied topically in the management of various disorders in which corticosteroids are indicated. (From Martindale, The Extra Pharmacopoeia, 30th ed, p739). triamcinolone : A C21-steroid hormone that is 1,4-pregnadiene-3,20-dione carrying four hydroxy substituents at positions 11beta, 16alpha, 17alpha and 21 as well as a fluoro substituent at position 9. Used in the form of its 16,17-acetonide to treat various skin infections.		2.372011beta-hydroxy steroid;
16alpha-hydroxy steroid;
17alpha-hydroxy steroid;
20-oxo steroid;
21-hydroxy steroid;
3-oxo-Delta(4) steroid;
C21-steroid hormone;
fluorinated steroid;
glucocorticoid;
primary alpha-hydroxy ketone;
tertiary alpha-hydroxy ketone		anti-allergic agent;
anti-inflammatory drug
clobetasol propionate
Clobetasol Propionate: This is the form in trademark preparations.. clobetasol propionate : The 17-O-propionate ester of clobetasol. A potent corticosteroid, it is used to treat various skin disorders, including exzema and psoriasis.		2.372011beta-hydroxy steroid;
20-oxo steroid;
3-oxo-Delta(1),Delta(4)-steroid;
chlorinated steroid;
fluorinated steroid;
glucocorticoid		anti-inflammatory drug
cefazolin
Cefazolin: A semisynthetic cephalosporin analog with broad-spectrum antibiotic action due to inhibition of bacterial cell wall synthesis. It attains high serum levels and is excreted quickly via the urine.. cefazolin : A first-generation cephalosporin compound having [(5-methyl-1,3,4-thiadiazol-2-yl)sulfanyl]methyl and (1H-tetrazol-1-ylacetyl)amino side-groups at positions 3 and 7 respectively.		2.0310beta-lactam antibiotic allergen;
cephalosporin;
tetrazoles;
thiadiazoles		antibacterial drug
timolol
(S)-timolol (anhydrous) : The (S)-(-) (more active) enantiomer of timolol. A beta-adrenergic antagonist, both the hemihydrate and the maleate salt are used in the mangement of glaucoma, hypertension, angina pectoris and myocardial infarction, and for the prevention of migraine.		3.8130timololanti-arrhythmia drug;
antiglaucoma drug;
antihypertensive agent;
beta-adrenergic antagonist
zidovudine
Zidovudine: A dideoxynucleoside compound in which the 3'-hydroxy group on the sugar moiety has been replaced by an azido group. This modification prevents the formation of phosphodiester linkages which are needed for the completion of nucleic acid chains. The compound is a potent inhibitor of HIV replication, acting as a chain-terminator of viral DNA during reverse transcription. It improves immunologic function, partially reverses the HIV-induced neurological dysfunction, and improves certain other clinical abnormalities associated with AIDS. Its principal toxic effect is dose-dependent suppression of bone marrow, resulting in anemia and leukopenia.. zidovudine : A pyrimidine 2',3'-dideoxyribonucleoside compound having a 3'-azido substituent and thymine as the nucleobase.		2.0310azide;
pyrimidine 2',3'-dideoxyribonucleoside		antimetabolite;
antiviral drug;
HIV-1 reverse transcriptase inhibitor
tobramycin
Tobramycin: An aminoglycoside, broad-spectrum antibiotic produced by Streptomyces tenebrarius. It is effective against gram-negative bacteria, especially the PSEUDOMONAS species. It is a 10% component of the antibiotic complex, NEBRAMYCIN, produced by the same species.. tobramycin : A amino cyclitol glycoside that is kanamycin B lacking the 3-hydroxy substituent from the 2,6-diaminoglucose ring.		2.3920amino cyclitol glycosideantibacterial agent;
antimicrobial agent;
toxin
ribavirin
Rebetron: Rebetron is tradename		2.03101-ribosyltriazole;
aromatic amide;
monocarboxylic acid amide;
primary carboxamide		anticoronaviral agent;
antiinfective agent;
antimetabolite;
antiviral agent;
EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor
diltiazem
Diltiazem: A benzothiazepine derivative with vasodilating action due to its antagonism of the actions of CALCIUM ion on membrane functions.. diltiazem : A 5-[2-(dimethylamino)ethyl]-2-(4-methoxyphenyl)-4-oxo-2,3,4,5-tetrahydro-1,5-benzothiazepin-3-yl acetate in which both stereocentres have S configuration. A calcium-channel blocker and vasodilator, it is used as the hydrochloride in the management of angina pectoris and hypertension.		2.03105-[2-(dimethylamino)ethyl]-2-(4-methoxyphenyl)-4-oxo-2,3,4,5-tetrahydro-1,5-benzothiazepin-3-yl acetateantihypertensive agent;
calcium channel blocker;
vasodilator agent
dexibuprofen
dexibuprofen: structure in first source		2.0310ibuprofennon-narcotic analgesic;
non-steroidal anti-inflammatory drug
torsemide
Torsemide: A pyridine and sulfonamide derivative that acts as a sodium-potassium chloride symporter inhibitor (loop diuretic). It is used for the treatment of EDEMA associated with CONGESTIVE HEART FAILURE; CHRONIC RENAL INSUFFICIENCY; and LIVER DISEASES. It is also used for the management of HYPERTENSION.. torasemide : An N-sulfonylurea obtained by formal condensation of [(3-methylphenyl)amino]pyridine-3-sulfonic acid with the free amino group of N-isopropylurea. It is a potent loop diuretic used for the treatment of hypertension and edema in patients with congestive heart failure.		2.0310aminopyridine;
N-sulfonylurea;
secondary amino compound		antihypertensive agent;
loop diuretic
idarubicin
Idarubicin: An orally administered anthracycline antineoplastic. The compound has shown activity against BREAST NEOPLASMS; LYMPHOMA; and LEUKEMIA.		2.0310anthracycline antibiotic;
deoxy hexoside;
monosaccharide derivative
endralazine
BQ 22-708: RN given refers to parent cpd		2.0310benzamides
cefaclor anhydrous
Cefaclor: Semisynthetic, broad-spectrum antibiotic derivative of CEPHALEXIN.. cefaclor : A cephalosporin bearing chloro and (R)-2-amino-2-phenylacetamido groups at positions 3 and 7, respectively, of the cephem skeleton.		2.0310cephalosporinantibacterial drug;
drug allergen
pirazolac
[no description available]		2.0310
lovastatin
Lovastatin: A fungal metabolite isolated from cultures of Aspergillus terreus. The compound is a potent anticholesteremic agent. It inhibits 3-hydroxy-3-methylglutaryl coenzyme A reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES), which is the rate-limiting enzyme in cholesterol biosynthesis. It also stimulates the production of low-density lipoprotein receptors in the liver.. lovastatin : A fatty acid ester that is mevastatin carrying an additional methyl group on the carbobicyclic skeleton. It is used in as an anticholesteremic drug and has been found in fungal species such as Aspergillus terreus and Pleurotus ostreatus (oyster mushroom).		2.0310delta-lactone;
fatty acid ester;
hexahydronaphthalenes;
polyketide;
statin (naturally occurring)		anticholesteremic drug;
antineoplastic agent;
Aspergillus metabolite;
prodrug
enoximone
Enoximone: A selective phosphodiesterase inhibitor with vasodilating and positive inotropic activity that does not cause changes in myocardial oxygen consumption. It is used in patients with CONGESTIVE HEART FAILURE.		2.0310aromatic ketone
simvastatin
Simvastatin: A derivative of LOVASTATIN and potent competitive inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES), which is the rate-limiting enzyme in cholesterol biosynthesis. It may also interfere with steroid hormone production. Due to the induction of hepatic LDL RECEPTORS, it increases breakdown of LDL CHOLESTEROL.. simvastatin : A member of the class of hexahydronaphthalenes that is lovastatin in which the 2-methylbutyrate ester moiety has been replaced by a 2,2-dimethylbutyrate ester group. It is used as a cholesterol-lowering and anti-cardiovascular disease drug.		2.0310delta-lactone;
fatty acid ester;
hexahydronaphthalenes;
statin (semi-synthetic)		EC 1.1.1.34/EC 1.1.1.88 (hydroxymethylglutaryl-CoA reductase) inhibitor;
EC 3.4.24.83 (anthrax lethal factor endopeptidase) inhibitor;
ferroptosis inducer;
geroprotector;
prodrug
pravastatin
Pravastatin: An antilipemic fungal metabolite isolated from cultures of Nocardia autotrophica. It acts as a competitive inhibitor of HMG CoA reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES).. pravastatin : A carboxylic ester resulting from the formal condensation of (S)-2-methylbutyric acid with the hydroxy group adjacent to the ring junction of (3R,5R)-7-[(1S,2S,6S,8S,8aR)-6,8-dihydroxy-2-methyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoic acid. Derived from microbial transformation of mevastatin, pravastatin is a reversible inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA). The sodium salt is used for lowering cholesterol and preventing cardiovascular disease. It is one of the lower potency statins, but has the advantage of fewer side effects compared with lovastatin and simvastatin.		2.03103-hydroxy carboxylic acid;
carbobicyclic compound;
carboxylic ester;
hydroxy monocarboxylic acid;
secondary alcohol;
statin (semi-synthetic)		anticholesteremic drug;
environmental contaminant;
metabolite;
xenobiotic
atomoxetine
atomoxetine : A secondary amino compound having methyl and 3-(2-methylphenoxy)-3-phenylpropan-1-yl substituents.		2.0310aromatic ether;
secondary amino compound;
toluenes		adrenergic uptake inhibitor;
antidepressant;
environmental contaminant;
xenobiotic
eproxindine
eproxindine: structure given in first source		2.0310
(S)-nomifensine
(S)-nomifensine : The S enantiomer of nomifensine.		2.0310nomifensine
(2S)-2-[[oxo-(4-propan-2-ylcyclohexyl)methyl]amino]-3-phenylpropanoic acid
[no description available]		2.0310phenylalanine derivative
tiagabine
Tiagabine: A nipecotic acid derivative that acts as a GABA uptake inhibitor and anticonvulsant agent. It is used in the treatment of EPILEPSY, for refractory PARTIAL SEIZURES.. tiagabine : A piperidinemonocarboxylic acid that is (R)-nipecotic acid in which the hydrogen attached to the nitrogen has been replaced by a 1,1-bis(3-methyl-2-thienyl)but-1-en-4-yl group. A GABA reuptake inhibitor, it is used (generally as the hydrochloride salt) for the treatment of epilepsy.		2.0310beta-amino acid;
piperidinemonocarboxylic acid;
tertiary amino compound;
thiophenes		anticonvulsant;
GABA reuptake inhibitor
topotecan
Topotecan: An antineoplastic agent used to treat ovarian cancer. It works by inhibiting DNA TOPOISOMERASES, TYPE I.. topotecan : A pyranoindolizinoquinoline used as an antineoplastic agent. It is a derivative of camptothecin and works by binding to the topoisomerase I-DNA complex and preventing religation of these 328 single strand breaks.		2.0310pyranoindolizinoquinolineantineoplastic agent;
EC 5.99.1.2 (DNA topoisomerase) inhibitor
atorvastatin
[no description available]		2.0310aromatic amide;
dihydroxy monocarboxylic acid;
monofluorobenzenes;
pyrroles;
statin (synthetic)		environmental contaminant;
xenobiotic
lamivudine
[no description available]		2.0310monothioacetal;
nucleoside analogue;
oxacycle;
primary alcohol		allergen;
anti-HBV agent;
antiviral drug;
EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor;
HIV-1 reverse transcriptase inhibitor;
prodrug
ziprasidone
ziprasidone: a benzisothiazoylpiperazine derivative; has combined dopamine and serotonin receptor antagonist activity; structurally related to tiospirone. ziprasidone : A piperazine compound having 1,2-benzothiazol-3-yl- and 2-(6-chloro-1,3-dihydro-2-oxindol-5-yl)ethyl substituents attached to the nitrogen atoms.		2.03101,2-benzisothiazole;
indolones;
organochlorine compound;
piperazines		antipsychotic agent;
dopaminergic antagonist;
histamine antagonist;
muscarinic antagonist;
psychotropic drug;
serotonergic antagonist
zolmitriptan
zolmitriptan: an antimigraine compound; a serotonin (5HT)-1D receptor agonist. zolmitriptan : A member of the class of tryptamines that is N,N-dimethyltryptamine in which the hydrogen at position 5 of the indole ring has been replaced by a [(4S)-2-oxo-1,3-oxazolidin-4-yl]methyl group. A serotonin 5-HT1 B and D receptor agonist, it is used for the treatment of migraine.		2.0310oxazolidinone;
tryptamines		anti-inflammatory drug;
serotonergic agonist;
vasoconstrictor agent
emtricitabine
Emtricitabine: A deoxycytidine analog and REVERSE TRANSCRIPTASE INHIBITOR with antiviral activity against HIV-1 and HEPATITIS B viruses. It is used to treat HIV INFECTIONS.. emtricitabine : An organofluorine compound that is 5-fluorocytosine substituted at the 1 position by a 2-(hydroxymethyl)-1,3-oxathiolan-5-yl group (2R,5S configuration). It is used in combination therapy for the treatment of HIV-1 infection.		2.0310monothioacetal;
nucleoside analogue;
organofluorine compound;
pyrimidone		antiviral drug;
HIV-1 reverse transcriptase inhibitor
pipothiazine
pipothiazine: was heading 1975-94 (see under PHENOTHIAZINE TRANQUILIZERS 1975-90); use PHENOTHIAZINES to search PIPOTHIAZINE 1975-94; a member of the family of phenothiazine tranquilizers		2.0310
beclomethasone 17-monopropionate
beclomethasone 17-monopropionate: ester of beclomethasone		2.3720
thiazolyl blue
thiazolyl blue: RN & II refers to bromide. 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide : The bromide salt of 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium.		1.9910organic bromide saltcolorimetric reagent;
dye
oseltamivir
Oseltamivir: An acetamido cyclohexene that is a structural homolog of SIALIC ACID and inhibits NEURAMINIDASE.. oseltamivir : A cyclohexenecarboxylate ester that is the ethyl ester of oseltamivir acid. An antiviral prodrug (it is hydrolysed to the active free carboxylic acid in the liver), it is used to slow the spread of influenza.		2.0310acetamides;
amino acid ester;
cyclohexenecarboxylate ester;
primary amino compound		antiviral drug;
EC 3.2.1.18 (exo-alpha-sialidase) inhibitor;
environmental contaminant;
prodrug;
xenobiotic
betamethasone sodium phosphate
betamethasone sodium phosphate: phosphate ester of betamethasone; RN given refers to the di-Na salt (11beta,16beta)-isomer; structure in Negwer,5th ed, 4975. betamethasone sodium phosphate : An organic sodium salt that is the disodium salt of betamethasone phosphate.		3.3411organic sodium salt;
tertiary alpha-hydroxy ketone
repaglinide
[no description available]		2.0310piperidines
dexfenfluramine
Dexfenfluramine: The S-isomer of FENFLURAMINE. It is a serotonin agonist and is used as an anorectic. Unlike fenfluramine, it does not possess any catecholamine agonist activity.. (S)-fenfluramine : The S-enantiomer of fenfluramine. It stimulates the release of serotonin and selectively inhibits its reuptake, but unlike fenfluramine it does not possess catecholamine agonist activity. It was formerly given by mouth as the hydrochloride in the treatment of obesity, but, like fenfluramine, was withdrawn wolrdwide following reports of valvular heart defects.		2.0310fenfluramineappetite depressant;
serotonergic agonist;
serotonin uptake inhibitor
drospirenone
drospirenone: a progestational compound with antimineralocorticoid and antiandrogenic activity; structure given in first source		2.03103-oxo-Delta(4) steroid;
steroid lactone		aldosterone antagonist;
contraceptive drug;
progestin
fenflumizole
fenflumizole: structure in first source		2.0310
clobetasone butyrate
[no description available]		3.3411organic molecular entity
(S)-flurbiprofen
[no description available]		2.0310flurbiprofen
atovaquone
Atovaquone: A hydroxynaphthoquinone that has antimicrobial activity and is being used in antimalarial protocols.. atovaquone : A naphthoquinone compound having a 4-(4-chlorophenyl)cyclohexyl group at the 2-position and a hydroxy substituent at the 3-position.		2.0310hydroxy-1,2-naphthoquinone
eletriptan
eletriptan: 5-HT(1B/1D) receptor agonist; structure in first source. eletriptan : An N-alkylpyrrolidine, that is N-methylpyrrolidine in which the pro-R hydrogen at position 2 is replaced by a {5-[2-(phenylsulfonyl)ethyl]-1H-indol-3-yl}methyl group.		2.0310indoles;
N-alkylpyrrolidine;
sulfone		non-steroidal anti-inflammatory drug;
serotonergic agonist;
vasoconstrictor agent
flunisolide
flunisolide: flunisolide HFA is a formulation of flunisolide using hydrofluoroalkane (HFA) as propellant in place of chlorofluorocarbon (CFC) ones		2.031011beta-hydroxy steroid;
20-oxo steroid;
21-hydroxy steroid;
3-oxo-Delta(1),Delta(4)-steroid;
cyclic ketal;
fluorinated steroid;
primary alpha-hydroxy ketone		anti-asthmatic drug;
anti-inflammatory drug;
immunosuppressive agent
clarithromycin
Clarithromycin: A semisynthetic macrolide antibiotic derived from ERYTHROMYCIN that is active against a variety of microorganisms. It can inhibit PROTEIN SYNTHESIS in BACTERIA by reversibly binding to the 50S ribosomal subunits. This inhibits the translocation of aminoacyl transfer-RNA and prevents peptide chain elongation.. clarithromycin : The 6-O-methyl ether of erythromycin A, clarithromycin is a macrolide antibiotic used in the treatment of respiratory-tract, skin and soft-tissue infections. It is also used to eradicate Helicobacter pylori in the treatment of peptic ulcer disease. It prevents bacteria from growing by interfering with their protein synthesis.		2.0310macrolide antibioticantibacterial drug;
environmental contaminant;
protein synthesis inhibitor;
xenobiotic
moexipril
[no description available]		2.0310peptide
nisone
Nisone: RN given refers to parent cpd		1.961011-oxo steroid;
17alpha-hydroxy steroid;
20-oxo steroid;
3-oxo-Delta(1),Delta(4)-steroid;
acetate ester;
steroid ester;
tertiary alpha-hydroxy ketone
fluocinolone
[no description available]		1.9610fluorinated steroid
diflucortolone valerate
diflucortolone valerate: Rn given refers to (6alpha,11beta,16alpha)-isomer		2.3720corticosteroid hormone
lekoptin
(S)-verapamil : A 2-(3,4-dimethoxyphenyl)-5-{[2-(3,4-dimethoxyphenyl)ethyl](methyl)amino}-2-(propan-2-yl)pentanenitrile that has S configuration.		2.03102-(3,4-dimethoxyphenyl)-5-{[2-(3,4-dimethoxyphenyl)ethyl](methyl)amino}-2-(propan-2-yl)pentanenitrile
tarenflurbil
tarenflurbil: R-enantiomer of flurbiprofen but not a COX inhibitor; modulates NF-kB, gamma-secretase, amyloid beta-protein;		2.0310flurbiprofen
bosentan anhydrous
Bosentan: A sulfonamide and pyrimidine derivative that acts as a dual endothelin receptor antagonist used to manage PULMONARY HYPERTENSION and SYSTEMIC SCLEROSIS.		2.0310primary alcohol;
pyrimidines;
sulfonamide		antihypertensive agent;
endothelin receptor antagonist
ibuprofen, (r)-isomer
[no description available]		2.0310ibuprofen
testosterone-17-sulfate
testosterone-17-sulfate: RN given refers to (17beta)-isomer. testosterone sulfate : A steroid sulfate that is testosterone substituted by a sulfoxy group at position 17.		1.96103-oxo-Delta(4) steroid;
androstanoid;
steroid sulfate		human urinary metabolite
pramipexole
Pramipexole: A benzothiazole derivative and dopamine agonist with antioxidant properties that is used in the treatment of PARKINSON DISEASE and RESTLESS LEGS SYNDROME.. pramipexole : A member of the class of benzothiazoles that is 4,5,6,7-tetrahydro-1,3-benzothiazole in which the hydrogens at the 2 and 6-pro-S-positions are substituted by amino and propylamino groups, respectively.		2.0310benzothiazoles;
diamine		antidyskinesia agent;
antiparkinson drug;
dopamine agonist;
radical scavenger
gadolinium 1,4,7,10-tetraazacyclododecane-n,n',n'',n'''-tetraacetate
gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate: RN refers to Na salt		2.1510
almotriptan
almotriptan : An indole compound having a 2-(dimethylamino)ethyl group at the 3-position and a (pyrrolidin-1-ylsulfonyl)methyl group at the 5-position.		2.0310indoles;
sulfonamide;
tertiary amine		non-steroidal anti-inflammatory drug;
serotonergic agonist;
vasoconstrictor agent
gefitinib
[no description available]		2.0310aromatic ether;
monochlorobenzenes;
monofluorobenzenes;
morpholines;
quinazolines;
secondary amino compound;
tertiary amino compound		antineoplastic agent;
epidermal growth factor receptor antagonist
bis(sulfosuccinimidyl)suberate
bis(sulfosuccinimidyl)suberate: structure given in first source		1.9910
methotrexate
[no description available]		2.0310dicarboxylic acid;
monocarboxylic acid amide;
pteridines		abortifacient;
antimetabolite;
antineoplastic agent;
antirheumatic drug;
dermatologic drug;
DNA synthesis inhibitor;
EC 1.5.1.3 (dihydrofolate reductase) inhibitor;
immunosuppressive agent
escitalopram
Escitalopram: S-enantiomer of CITALOPRAM. Belongs to a class of drugs known as SELECTIVE SEROTONIN REUPTAKE INHIBITORS, used to treat depression and generalized anxiety disorder.. escitalopram : A 1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-2-benzofuran-5-carbonitrile that has S-configuration at the chiral centre. It is the active enantiomer of citalopram.		2.03101-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-2-benzofuran-5-carbonitrileantidepressant;
EC 3.4.21.26 (prolyl oligopeptidase) inhibitor
levofloxacin
Levofloxacin: The L-isomer of Ofloxacin.. levofloxacin : An optically active form of ofloxacin having (S)-configuration; an inhibitor of bacterial topoisomerase IV and DNA gyrase.		2.03109-fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid;
fluoroquinolone antibiotic;
quinolone antibiotic		antibacterial drug;
DNA synthesis inhibitor;
EC 5.99.1.3 [DNA topoisomerase (ATP-hydrolysing)] inhibitor;
topoisomerase IV inhibitor
moxifloxacin
Moxifloxacin: A fluoroquinolone that acts as an inhibitor of DNA TOPOISOMERASE II and is used as a broad-spectrum antibacterial agent.. moxifloxacin : A quinolone that consists of 4-oxo-1,4-dihydroquinoline-3-carboxylic acid bearing a cyclopropyl substituent at position 1, a fluoro substitiuent at position 6, a (4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl group at position 7 and a methoxy substituent at position 8. A member of the fluoroquinolone class of antibacterial agents.		9.951210aromatic ether;
cyclopropanes;
fluoroquinolone antibiotic;
pyrrolidinopiperidine;
quinolinemonocarboxylic acid;
quinolone antibiotic;
quinolone		antibacterial drug
disopyramide, (s)-isomer
[no description available]		2.0310
isradipine, (s)-isomer
[no description available]		2.0310
olmesartan
olmesartan: an active metabolite of CS 866		2.0310biphenylyltetrazoleangiotensin receptor antagonist;
antihypertensive agent
ketoprofen
[no description available]		2.0310
prednisolone 21-3-sulfobenzoate
prednisolone 21-3-sulfobenzoate: RN given refers to parent cpd; structure		3.3511corticosteroid hormone
cortisone
[no description available]		1.961011-oxo steroid;
17alpha-hydroxy steroid;
20-oxo steroid;
21-hydroxy steroid;
3-oxo-Delta(4) steroid;
C21-steroid;
glucocorticoid;
primary alpha-hydroxy ketone;
tertiary alpha-hydroxy ketone		human metabolite;
mouse metabolite
fludrocortisone acetate
fludrocortisone acetate : An acetate ester resulting from the formal condensation of the primary hydroxy group of fludrocortisone with acetic acid. A synthetic corticosteroid, it has glucocorticoid actions about 10 times as potent as hydrocortisone, while its mineralocorticoid actions are over 100 times as potent. It is used in partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison's disease and for the treatment of salt-losing adrenal hyperplasia.		2.372011beta-hydroxy steroid;
17alpha-hydroxy steroid;
20-oxo steroid;
3-oxo-Delta(4) steroid;
acetate ester;
fluorinated steroid;
mineralocorticoid;
tertiary alpha-hydroxy ketone
epinastine
dexamethasone acetate: RN given refers to (11beta,16alpha)-isomer		2.3720corticosteroid hormone
medrysone
[no description available]		2.6530corticosteroid hormone
quinidine
Quinidine: An optical isomer of quinine, extracted from the bark of the CHINCHONA tree and similar plant species. This alkaloid dampens the excitability of cardiac and skeletal muscles by blocking sodium and potassium currents across cellular membranes. It prolongs cellular ACTION POTENTIALS, and decreases automaticity. Quinidine also blocks muscarinic and alpha-adrenergic neurotransmission.. quinidine : A cinchona alkaloid consisting of cinchonine with the hydrogen at the 6-position of the quinoline ring substituted by methoxy.		2.4520cinchona alkaloidalpha-adrenergic antagonist;
anti-arrhythmia drug;
antimalarial;
drug allergen;
EC 1.14.13.181 (13-deoxydaunorubicin hydroxylase) inhibitor;
EC 3.6.3.44 (xenobiotic-transporting ATPase) inhibitor;
muscarinic antagonist;
P450 inhibitor;
potassium channel blocker;
sodium channel blocker
digitoxin
Digitoxin: A cardiac glycoside sometimes used in place of DIGOXIN. It has a longer half-life than digoxin; toxic effects, which are similar to those of digoxin, are longer lasting. (From Martindale, The Extra Pharmacopoeia, 30th ed, p665). digitoxin : A cardenolide glycoside in which the 3beta-hydroxy group of digitoxigenin carries a 2,6-dideoxy-beta-D-ribo-hexopyranosyl-(1->4)-2,6-dideoxy-beta-D-ribo-hexopyranosyl-(1->4)-2,6-dideoxy-beta-D-ribo-hexopyranosyl trisaccharide chain.		2.0310cardenolide glycosideEC 3.6.3.9 (Na(+)/K(+)-transporting ATPase) inhibitor
saquinavir
Saquinavir: An HIV protease inhibitor which acts as an analog of an HIV protease cleavage site. It is a highly specific inhibitor of HIV-1 and HIV-2 proteases, and also inhibits CYTOCHROME P-450 CYP3A.. saquinavir : An aspartic acid derivative obtained by formal condensation of the primary amino group of (2S,3R)-4-[(3S,4aS,8aS)-3-(tert-butylcarbamoyl)octahydroisoquinolin-2(1H)-yl]-3-hydroxy-1-phenylbutan-2-ylamine with the carboxy group of N(2)(-quinolin-2-ylcarbonyl)-L-asparagine. An inhibitor of HIV-1 protease.		2.0310L-asparagine derivative;
quinolines		antiviral drug;
HIV protease inhibitor
abacavir
abacavir: a carbocyclic nucleoside with potent selective anti-HIV activity. abacavir : A 2,6-diaminopurine that is (1S)-cyclopent-2-en-1-ylmethanol in which the pro-R hydrogen at the 4-position is substituted by a 2-amino-6-(cyclopropylamino)-9H-purin-9-yl group. A nucleoside analogue reverse transcriptase inhibitor (NRTI) with antiretroviral activity against HIV, it is used (particularly as the sulfate) with other antiretrovirals in combination therapy of HIV infection.		2.03102,6-diaminopurinesantiviral drug;
drug allergen;
HIV-1 reverse transcriptase inhibitor
linezolid
[no description available]		2.0310acetamides;
morpholines;
organofluorine compound;
oxazolidinone		antibacterial drug;
protein synthesis inhibitor
chloramphenicol palmitate
chloramphenicol palmitate: RN given refers to ((R-(R*,R*))-isomer)		2.0310hexadecanoate ester
difluprednate
difluprednate: RN given refers to (6alpha,11beta)-isomer		2.3720butyrate ester;
corticosteroid hormone
halcinonide
Halcinonide: A glucocorticoid used topically in the treatment of DERMATITIS; ECZEMA; or PSORIASIS. It may cause skin irritation.		2.3720organic molecular entitySMO receptor agonist
betamethasone acetate
[no description available]		2.372011beta-hydroxy steroid;
17alpha-hydroxy steroid;
20-oxo steroid;
3-oxo-Delta(1),Delta(4)-steroid;
acetate ester;
fluorinated steroid;
steroid ester;
tertiary alpha-hydroxy ketone
flumethasone pivalate
flumethasone pivalate: structure		2.372011beta-hydroxy steroid;
17alpha-hydroxy steroid;
20-oxo steroid;
3-oxo-Delta(1),Delta(4)-steroid;
fluorinated steroid;
glucocorticoid;
pivalate ester;
tertiary alpha-hydroxy ketone		anti-inflammatory drug;
antipruritic drug
loteprednol etabonate
Loteprednol Etabonate: An androstadiene derivative corticosteroid that is used as an ANTI-ALLERGIC AGENT for the treatment of inflammatory and allergic eye conditions.		2.051011beta-hydroxy steroid;
3-oxo-Delta(1),Delta(4)-steroid;
etabonate ester;
organochlorine compound;
steroid acid ester;
steroid ester		anti-inflammatory drug
betadex
beta-Cyclodextrins: Cyclic GLUCANS consisting of seven (7) glucopyranose units linked by 1,4-glycosidic bonds.		2.0710cyclodextrin
tacrolimus
Tacrolimus: A macrolide isolated from the culture broth of a strain of Streptomyces tsukubaensis that has strong immunosuppressive activity in vivo and prevents the activation of T-lymphocytes in response to antigenic or mitogenic stimulation in vitro.. tacrolimus (anhydrous) : A macrolide lactam containing a 23-membered lactone ring, originally isolated from the fermentation broth of a Japanese soil sample that contained the bacteria Streptomyces tsukubaensis.		2.0310macrolide lactambacterial metabolite;
immunosuppressive agent
mycophenolic acid
Mycophenolic Acid: Compound derived from Penicillium stoloniferum and related species. It blocks de novo biosynthesis of purine nucleotides by inhibition of the enzyme inosine monophosphate dehydrogenase (IMP DEHYDROGENASE). Mycophenolic acid exerts selective effects on the immune system in which it prevents the proliferation of T-CELLS, LYMPHOCYTES, and the formation of antibodies from B-CELLS. It may also inhibit recruitment of LEUKOCYTES to sites of INFLAMMATION.. mycophenolate : A monocarboxylic acid anion resulting from the removal of a proton from the carboxy group of mycophenolic acid.. mycophenolic acid : A member of the class of 2-benzofurans that is 2-benzofuran-1(3H)-one which is substituted at positions 4, 5, 6, and 7 by methyl, methoxy, (2E)-5-carboxy-3-methylpent-2-en-1-yl, and hydroxy groups, respectively. It is an antibiotic produced by Penicillium brevi-compactum, P. stoloniferum, P. echinulatum and related species. An immunosuppressant, it is widely used (partiularly as its sodium salt and as the 2-(morpholin-4-yl)ethyl ester prodrug, mycophenolate mofetil) to prevent tissue rejection following organ transplants and for the treatment of certain autoimmune diseases.		2.03102-benzofurans;
gamma-lactone;
monocarboxylic acid;
phenols		anticoronaviral agent;
antimicrobial agent;
antineoplastic agent;
EC 1.1.1.205 (IMP dehydrogenase) inhibitor;
environmental contaminant;
immunosuppressive agent;
mycotoxin;
Penicillium metabolite;
xenobiotic
melphalan
Melphalan: An alkylating nitrogen mustard that is used as an antineoplastic in the form of the levo isomer - MELPHALAN, the racemic mixture - MERPHALAN, and the dextro isomer - MEDPHALAN; toxic to bone marrow, but little vesicant action; potential carcinogen.. melphalan : A phenylalanine derivative comprising L-phenylalanine having [bis(2-chloroethyl)amino group at the 4-position on the phenyl ring.		2.0310L-phenylalanine derivative;
nitrogen mustard;
non-proteinogenic L-alpha-amino acid;
organochlorine compound		alkylating agent;
antineoplastic agent;
carcinogenic agent;
drug allergen;
immunosuppressive agent
chloroquine diphosphate
[no description available]		2.0310chloroquine
dextromethadone
D-methadone: an NMDA receptor antagonist analgesic that lacks opioid activity. dextromethadone : A 6-(dimethylamino)-4,4-diphenylheptan-3-one that has (S)-configuration. It is the less active enantiomer of methadone and has very little activity on opioid receptors and mainly responsible for the inhibition of hERG K+ channels and thus for cardiac toxicity. The drug is currently under clinical development for the treatment of major depressive disorder.		2.03106-(dimethylamino)-4,4-diphenylheptan-3-oneNMDA receptor antagonist;
opioid analgesic
prednisolone hemisuccinate
prednisolone hemisuccinate: RN given refers to (11 beta)-isomer. prednisolone succinate : A hemisuccinate resulting from the formal condensation of the 21-hydroxy group prednisolone with one of the carboxy groups of succinic acid. It is used to treat mild to moderate non-infectious eye allergies and inflammation, including damage caused by chemical and thermal burns.		2.372011beta-hydroxy steroid;
17alpha-hydroxy steroid;
20-oxo steroid;
3-oxo-Delta(1),Delta(4)-steroid;
hemisuccinate;
tertiary alpha-hydroxy ketone		anti-inflammatory drug
propylthiouracil
Propylthiouracil: A thiourea antithyroid agent. Propythiouracil inhibits the synthesis of thyroxine and inhibits the peripheral conversion of throxine to tri-iodothyronine. It is used in the treatment of hyperthyroidism. (From Martindale, The Extra Pharmacopeoia, 30th ed, p534). 6-propyl-2-thiouracil : A pyrimidinethione consisting of uracil in which the 2-oxo group is substituted by a thio group and the hydrogen at position 6 is substituted by a propyl group.		2.0310pyrimidinethioneantidote to paracetamol poisoning;
antimetabolite;
antioxidant;
antithyroid drug;
carcinogenic agent;
EC 1.14.13.39 (nitric oxide synthase) inhibitor;
hormone antagonist
dexketoprofen
dexketoprofen : A monocarboxylic acid that is (S)-hydratropic acid substituted at position 3 on the phenyl ring by a benzoyl group. A cyclooxygenase inhibitor, it is used to relieve short-term pain, such as muscular pain, dental pain and dysmenorrhoea.		2.0310benzophenones;
monocarboxylic acid		cyclooxygenase 1 inhibitor;
cyclooxygenase 2 inhibitor;
non-narcotic analgesic;
non-steroidal anti-inflammatory drug
ondansetron, (s)-isomer
[no description available]		2.0310
eszopiclone
Eszopiclone: A pyridine, pyrazine, and piperazine derivative that is used as a HYPNOTIC AND SEDATIVE in the treatment of INSOMNIA.. eszopiclone : The (5S)- (active) enantiomer of zopiclone. Unlike almost all other hypnotic sedatives, which are approved only for the relief of short-term (6-8 weeks) insomnia, eszopiclone is approved by the U.S. Food and Drug Administration for long-term use.		2.0310zopiclonecentral nervous system depressant;
sedative
methimazole
Methimazole: A thioureylene antithyroid agent that inhibits the formation of thyroid hormones by interfering with the incorporation of iodine into tyrosyl residues of thyroglobulin. This is done by interfering with the oxidation of iodide ion and iodotyrosyl groups through inhibition of the peroxidase enzyme.. methimazole : A member of the class of imidazoles that it imidazole-2-thione in which a methyl group replaces the hydrogen which is attached to a nitrogen.		2.03101,3-dihydroimidazole-2-thionesantithyroid drug
digoxin
Digoxin: A cardiotonic glycoside obtained mainly from Digitalis lanata; it consists of three sugars and the aglycone DIGOXIGENIN. Digoxin has positive inotropic and negative chronotropic activity. It is used to control ventricular rate in ATRIAL FIBRILLATION and in the management of congestive heart failure with atrial fibrillation. Its use in congestive heart failure and sinus rhythm is less certain. The margin between toxic and therapeutic doses is small. (From Martindale, The Extra Pharmacopoeia, 30th ed, p666). digoxin : A cardenolide glycoside that is digitoxin beta-hydroxylated at C-12. A cardiac glycoside extracted from the foxglove plant, Digitalis lanata, it is used to control ventricular rate in atrial fibrillation and in the management of congestive heart failure with atrial fibrillation, but the margin between toxic and therapeutic doses is small.		2.0310cardenolide glycoside;
steroid saponin		anti-arrhythmia drug;
cardiotonic drug;
EC 3.6.3.9 (Na(+)/K(+)-transporting ATPase) inhibitor;
epitope
hmr 3647
[no description available]		2.0310
tocainide, (s)-isomer
[no description available]		2.0310
calcitriol
dihydroxy-vitamin D3: as a major in vitro metabolite of 1alpha,25-dihydroxyvitamin D3, produced in primary cultures of neonatal human keratinocytes		2.0310D3 vitamins;
hydroxycalciol;
triol		antineoplastic agent;
antipsoriatic;
bone density conservation agent;
calcium channel agonist;
calcium channel modulator;
hormone;
human metabolite;
immunomodulator;
metabolite;
mouse metabolite;
nutraceutical
leukotriene b4
Leukotriene B4: The major metabolite in neutrophil polymorphonuclear leukocytes. It stimulates polymorphonuclear cell function (degranulation, formation of oxygen-centered free radicals, arachidonic acid release, and metabolism). (From Dictionary of Prostaglandins and Related Compounds, 1990). leukotriene B4 : A leukotriene composed of (6Z,8E,10E,14Z)-icosatetraenoic acid having (5S)- and (12R)-hydroxy substituents. It is a lipid mediator of inflammation that is generated from arachidonic acid via the 5-lipoxygenase pathway.		210dihydroxy monocarboxylic acid;
hydroxy polyunsaturated fatty acid;
leukotriene;
long-chain fatty acid		human metabolite;
mouse metabolite;
plant metabolite;
vasoconstrictor agent
clavulanic acid
Clavulanic Acid: A beta-lactam antibiotic produced by the actinobacterium Streptomyces clavuligerus. It is a suicide inhibitor of bacterial beta-lactamase enzymes. Administered alone, it has only weak antibacterial activity against most organisms, but given in combination with other beta-lactam antibiotics it prevents antibiotic inactivation by microbial lactamase.. clavulanate : The conjugate base of clavulanic acid.. clavulanic acid : Antibiotic isolated from Streptomyces clavuligerus. It acts as a suicide inhibitor of bacterial beta-lactamase enzymes.		2.0310oxapenamantibacterial drug;
anxiolytic drug;
bacterial metabolite;
EC 3.5.2.6 (beta-lactamase) inhibitor
pulmicort
Budesonide: A glucocorticoid used in the management of ASTHMA, the treatment of various skin disorders, and allergic RHINITIS.. budesonide : A glucocorticoid steroid having a highly oxygenated pregna-1,4-diene structure. It is used mainly in the treatment of asthma and non-infectious rhinitis and for treatment and prevention of nasal polyposis.		2.964011beta-hydroxy steroid;
20-oxo steroid;
21-hydroxy steroid;
3-oxo-Delta(1),Delta(4)-steroid;
cyclic acetal;
glucocorticoid;
primary alpha-hydroxy ketone		anti-inflammatory drug;
bronchodilator agent;
drug allergen
montelukast
montelukast: a leukotriene D4 receptor antagonist		2.0310aliphatic sulfide;
monocarboxylic acid;
quinolines		anti-arrhythmia drug;
anti-asthmatic drug;
leukotriene antagonist
codeine
[no description available]		2.0310morphinane alkaloid;
organic heteropentacyclic compound		antitussive;
drug allergen;
environmental contaminant;
opioid analgesic;
opioid receptor agonist;
prodrug;
xenobiotic
hydromorphone
Hydromorphone: An opioid analgesic made from MORPHINE and used mainly as an analgesic. It has a shorter duration of action than morphine.. hydromorphone : A morphinane alkaloid that is a hydrogenated ketone derivative of morphine. A semi-synthetic drug, it is a centrally acting pain medication of the opioid class.		2.0310morphinane alkaloid;
organic heteropentacyclic compound		mu-opioid receptor agonist;
opioid analgesic
naloxone
Naloxone: A specific opiate antagonist that has no agonist activity. It is a competitive antagonist at mu, delta, and kappa opioid receptors.. naloxone : A synthetic morphinane alkaloid that is morphinone in which the enone double bond has been reduced to a single bond, the hydrogen at position 14 has been replaced by a hydroxy group, and the methyl group attached to the nitrogen has been replaced by an allyl group. A specific opioid antagonist, it is used (commonly as its hydrochloride salt) to reverse the effects of opioids, both following their use of opioids during surgery and in cases of known or suspected opioid overdose.		2.0310morphinane alkaloid;
organic heteropentacyclic compound;
tertiary alcohol		antidote to opioid poisoning;
central nervous system depressant;
mu-opioid receptor antagonist
proscillaridin
Proscillaridin: A cardiotonic glycoside isolated from Scilla maritima var. alba (Squill).		2.0310organic molecular entity
sirolimus
Sirolimus: A macrolide compound obtained from Streptomyces hygroscopicus that acts by selectively blocking the transcriptional activation of cytokines thereby inhibiting cytokine production. It is bioactive only when bound to IMMUNOPHILINS. Sirolimus is a potent immunosuppressant and possesses both antifungal and antineoplastic properties.. sirolimus : A macrolide lactam isolated from Streptomyces hygroscopicus consisting of a 29-membered ring containing 4 trans double bonds, three of which are conjugated. It is an antibiotic, immunosupressive and antineoplastic agent.		2.0310antibiotic antifungal drug;
cyclic acetal;
cyclic ketone;
ether;
macrolide lactam;
organic heterotricyclic compound;
secondary alcohol		antibacterial drug;
anticoronaviral agent;
antineoplastic agent;
bacterial metabolite;
geroprotector;
immunosuppressive agent;
mTOR inhibitor
topiramate
Topiramate: A sulfamate-substituted fructose analog that was originally identified as a hypoglycemic agent. It is used for the treatment of EPILEPSY and MIGRAINE DISORDERS, and may also promote weight loss.. topiramate : A hexose derivative that is 2,3:4,5-di-O-isopropylidene-beta-D-fructopyranose in which the hydroxy group has been converted to the corresponding sulfamate ester. It blocks voltage-dependent sodium channels and is used as an antiepileptic and for the prevention of migraine.		2.0310cyclic ketal;
ketohexose derivative;
sulfamate ester		anticonvulsant;
sodium channel blocker
morphine
Meconium: The thick green-to-black mucilaginous material found in the intestines of a full-term fetus. It consists of secretions of the INTESTINAL GLANDS; BILE PIGMENTS; FATTY ACIDS; AMNIOTIC FLUID; and intrauterine debris. It constitutes the first stools passed by a newborn.		2.0310morphinane alkaloid;
organic heteropentacyclic compound;
tertiary amino compound		anaesthetic;
drug allergen;
environmental contaminant;
geroprotector;
mu-opioid receptor agonist;
opioid analgesic;
plant metabolite;
vasodilator agent;
xenobiotic
clobetasol
Clobetasol: A derivative of PREDNISOLONE with high glucocorticoid activity and low mineralocorticoid activity. Absorbed through the skin faster than FLUOCINONIDE, it is used topically in treatment of PSORIASIS but may cause marked adrenocortical suppression.. clobetasol : A 3-oxo-Delta(1),Delta(4)-steroid that is 16beta-methylpregna-1,4-diene-3,20-dione bearing hydroxy groups at the 11beta and 17alpha positions, fluorine at position 9, and a chlorine substituent at position 21. It is used as its 17alpha-propionate ester to treat various skin disorders, including exzema and psoriasis.		3.341111beta-hydroxy steroid;
17alpha-hydroxy steroid;
20-oxo steroid;
3-oxo-Delta(1),Delta(4)-steroid;
chlorinated steroid;
fluorinated steroid;
glucocorticoid;
tertiary alpha-hydroxy ketone		anti-inflammatory drug;
SMO receptor agonist
desonide
Desonide: A nonfluorinated corticosteroid anti-inflammatory agent used topically for DERMATOSES.. desonide : Triamcinolone acetonide with hydrogen instead of the fluorine substituent at position 9. A corticosteroid anti-inflammatory, it is used topically as a cream, ointment or lotion for the treatment of various skin disorders.		2.372011beta-hydroxy steroid;
20-oxo steroid;
21-hydroxy steroid;
3-oxo-Delta(1),Delta(4)-steroid;
corticosteroid;
cyclic ketal;
primary alpha-hydroxy ketone		anti-inflammatory drug
fluticasone
Fluticasone: A STEROID with GLUCOCORTICOID RECEPTOR activity that is used to manage the symptoms of ASTHMA; ALLERGIC RHINITIS, and ATOPIC DERMATITIS.. fluticasone : A trifluorinated corticosteroid used in the form of its propionate ester for treatment of allergic rhinitis.		2.031011beta-hydroxy steroid;
17alpha-hydroxy steroid;
3-oxo-Delta(4) steroid;
corticosteroid;
fluorinated steroid;
thioester		anti-allergic agent;
anti-asthmatic drug
nalbuphine
Nalbuphine: A narcotic used as a pain medication. It appears to be an agonist at KAPPA RECEPTORS and an antagonist or partial agonist at MU RECEPTORS.		2.0310organic heteropentacyclic compoundmu-opioid receptor antagonist;
opioid analgesic
(6E)-7-[3-(4-fluorophenyl)-1-(propan-2-yl)-1H-indol-2-yl]-3,5-dihydroxyhept-6-enoic acid
(6E)-7-[3-(4-fluorophenyl)-1-(propan-2-yl)-1H-indol-2-yl]-3,5-dihydroxyhept-6-enoic acid : A dihydroxy monocarboxylic acid that is N-isopropylindole which is substituted at position 3 by a p-fluorophenyl group and at position 2 by a 6-carboxy-3,5-dihydroxyhex-1-en-1-yl group. It has four possible diastereoisomers.		2.0310dihydroxy monocarboxylic acid;
indoles;
organofluorine compound
naltrexone
Naltrexone: Derivative of noroxymorphone that is the N-cyclopropylmethyl congener of NALOXONE. It is a narcotic antagonist that is effective orally, longer lasting and more potent than naloxone, and has been proposed for the treatment of heroin addiction. The FDA has approved naltrexone for the treatment of alcohol dependence.. naltrexone : An organic heteropentacyclic compound that is naloxone substituted in which the allyl group attached to the nitrogen is replaced by a cyclopropylmethyl group. A mu-opioid receptor antagonist, it is used to treat alcohol dependence.		2.0310cyclopropanes;
morphinane-like compound;
organic heteropentacyclic compound		antidote to opioid poisoning;
central nervous system depressant;
environmental contaminant;
mu-opioid receptor antagonist;
xenobiotic
enalapril
Enalapril: An angiotensin-converting enzyme inhibitor that is used to treat HYPERTENSION and HEART FAILURE.. enalapril : A dicarboxylic acid monoester that is ethyl 4-phenylbutanoate in which a hydrogen alpha to the carboxy group is substituted by the amino group of L-alanyl-L-proline (S-configuration).		2.0310dicarboxylic acid monoester;
dipeptide		antihypertensive agent;
EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor;
geroprotector;
prodrug
trandolapril
trandolapril : A heterobicylic compound that is (2S,3aR,7aS)-1-[(2S)-2-aminopropanoyl]octahydro-1H-indole-2-carboxylic acid in which the hydrogen of the amino group is substituted by a (2R)-1-ethoxy-1-oxo-4-phenylbutan-2-yl group. It is a angiotensin-converting enzyme inhibitor and a prodrug used for the treatment of hypertension.		2.0310dicarboxylic acid monoester;
dipeptide;
ethyl ester;
organic heterobicyclic compound;
secondary amino compound;
tertiary carboxamide		antihypertensive agent;
EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor;
prodrug
(R)-citalopram
(R)-citalopram : A 1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-2-benzofuran-5-carbonitrile that has R-configuration at the chiral centre. It is the inactive enantiomer of citalopram.		2.03101-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-2-benzofuran-5-carbonitrile
1-methyl-d-lysergic acid butanolamide
[no description available]		2.0310ergot alkaloid;
monocarboxylic acid amide		serotonergic antagonist;
sympatholytic agent;
vasoconstrictor agent
nitrofurantoin
Nitrofurantoin: A urinary anti-infective agent effective against most gram-positive and gram-negative organisms. Although sulfonamides and antibiotics are usually the agents of choice for urinary tract infections, nitrofurantoin is widely used for prophylaxis and long-term suppression.. nitrofurantoin : An imidazolidine-2,4-dione that is hydantoin substituted at position 1 by a [(5-nitro-2-furyl)methylene]amino group. An antibiotic that damages bacterial DNA.		2.0310imidazolidine-2,4-dione;
nitrofuran antibiotic;
organonitrogen heterocyclic antibiotic;
organooxygen heterocyclic antibiotic		antibacterial drug;
antiinfective agent;
hepatotoxic agent
dutasteride
Dutasteride: A 5-ALPHA-REDUCTASE INHIBITOR that is reported to inhibit both type-1 and type2 isoforms of the enzyme and is used to treat BENIGN PROSTATIC HYPERPLASIA.. dutasteride : An aza-steroid that is inasteride in which the tert-butyl group is replaced by a 2,5-bis(trifluoromethyl)phenyl group. A synthetic 4-azasteroid, dutasteride is a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5alpha-reductase, an intracellular enzyme that converts testosterone to 5alpha-dihydrotestosterone. Dutasteride is used for the treatment of symptomatic benign prostatic hyperplasia in men with an enlarged prostate gland.		2.0310(trifluoromethyl)benzenes;
aza-steroid;
delta-lactam		antihyperplasia drug;
EC 1.3.1.22 [3-oxo-5alpha-steroid 4-dehydrogenase (NADP(+))] inhibitor
gemifloxacin
Gemifloxacin: A naphthyridine and fluoroquinolone derivative antibacterial agent and DNA TOPOISOMERASE II inhibitor that is used for the treatment of community-acquired pneumonia and acute bacterial infections associated with chronic bronchitis.. gemifloxacin : A 1,4-dihydro-1,8-naphthyridine with a carboxy group at the 3-position, an oxo sustituent at the 4-position, a fluoro substituent at the 5-position and a substituted pyrrolin-1-yl group at the 7-position.		2.03101,8-naphthyridine derivative;
fluoroquinolone antibiotic;
monocarboxylic acid;
quinolone antibiotic		antibacterial drug;
antimicrobial agent;
topoisomerase IV inhibitor
3,5-dipentadecyloxybenzamidine hydrochloride
3,5-dipentadecyloxybenzamidine hydrochloride: structure in first source		2.4420
norfenfluramine
Dexnorfenfluramine: D-isomer of Norfenfluramine		2.0310amphetamines
milnacipran
[no description available]		2.0310acetamides
acid phosphatase
Acid Phosphatase: An enzyme that catalyzes the conversion of an orthophosphoric monoester and water to an alcohol and orthophosphate. EC 3.1.3.2.		2.0610
cosyntropin
Cosyntropin: A synthetic peptide that is identical to the 24-amino acid segment at the N-terminal of ADRENOCORTICOTROPIC HORMONE. ACTH (1-24), a segment similar in all species, contains the biological activity that stimulates production of CORTICOSTEROIDS in the ADRENAL CORTEX.. cosyntropin : A synthetic peptide that is identical to the 24-amino acid segment at the N-terminal of adrenocorticotropic hormone (corticotropin). A segment similar in all species, it contains the biological activity that stimulates production of corticosteroids in the adrenal cortex. It is used diagnostically to investigate adrenocortical insufficiency.		3.3511
adrenocorticotropin zinc
[no description available]		3.3511
(9R)-9-chloro-11,17-dihydroxy-17-(2-hydroxy-1-oxoethyl)-10,13,16-trimethyl-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-3-one
Beclomethasone: An anti-inflammatory, synthetic glucocorticoid. It is used topically as an anti-inflammatory agent and in aerosol form for the treatment of ASTHMA.. beclomethasone : A 17alpha-hydroxy steroid that is prednisolone in which the hydrogens at the 9alpha and 16beta positions are substituted by a chlorine and a methyl group, respectively.		4.973321-hydroxy steroid
sodium salicylate
[no description available]		1.9610organic molecular entity
chitosan
[no description available]		1.9910
cortisol succinate, sodium salt
hydrocortisone hemisuccinate: RN given refers to (11beta)-isomer; Synonyms Solu-Cortef & sopolcort H refer to Na salt		1.9610organic molecular entity
interleukin-8
Interleukin-8: A member of the CXC chemokine family that plays a role in the regulation of the acute inflammatory response. It is secreted by variety of cell types and induces CHEMOTAXIS of NEUTROPHILS and other inflammatory cells.		2.0310
tetracycline
Tetracycline: A naphthacene antibiotic that inhibits AMINO ACYL TRNA binding during protein synthesis.. tetracycline : A broad-spectrum polyketide antibiotic produced by the Streptomyces genus of actinobacteria.		2.3920
chlortetracycline
Chlortetracycline: A TETRACYCLINE with a 7-chloro substitution.. chlortetracycline : A member of the class of tetracyclines with formula C22H23ClN2O8 isolated from Streptomyces aureofaciens.		2.0310
oxytetracycline, anhydrous
Oxytetracycline: A TETRACYCLINE analog isolated from the actinomycete STREPTOMYCES RIMOSUS and used in a wide variety of clinical conditions.. oxytetracycline : A tetracycline used for treatment of infections caused by a variety of Gram positive and Gram negative microorganisms including Mycoplasma pneumoniae, Pasteurella pestis, Escherichia coli, Haemophilus influenzae (respiratory infections), and Diplococcus pneumoniae.		2.0310
minocycline
Minocycline: A TETRACYCLINE analog, having a 7-dimethylamino and lacking the 5 methyl and hydroxyl groups, which is effective against tetracycline-resistant STAPHYLOCOCCUS infections.. minocycline : A tetracycline analogue having a dimethylamino group at position 7 and lacking the methyl and hydroxy groups at position 5.		2.0310
methacycline
Methacycline: A broad-spectrum semisynthetic antibiotic related to TETRACYCLINE but excreted more slowly and maintaining effective blood levels for a more extended period.. methacycline : A tetracycline that is the 6-methylene analogue of oxytetracycline, obtained by formal dehydration at position 6.		2.0310
piroxicam
[no description available]		2.0310benzothiazine;
monocarboxylic acid amide;
pyridines		analgesic;
antirheumatic drug;
cyclooxygenase 1 inhibitor;
EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor;
non-steroidal anti-inflammatory drug
(S)-warfarin
(S)-warfarin : A 4-hydroxy-3-(3-oxo-1-phenylbutyl)-2H-1-benzopyran-2-one that has (S)-configuration (the racemate is warfarin, an anticoagulant drug and rodenticide).		2.03104-hydroxy-3-(3-oxo-1-phenylbutyl)-1-benzopyran-2-one
norgestrel
Norgestrel: A synthetic progestational agent with actions similar to those of PROGESTERONE. This racemic or (+-)-form has about half the potency of the levo form (LEVONORGESTREL). Norgestrel is used as a contraceptive, ovulation inhibitor, and for the control of menstrual disorders and endometriosis.		1.9610
cyclosporine
Cyclosporine: A cyclic undecapeptide from an extract of soil fungi. It is a powerful immunosupressant with a specific action on T-lymphocytes. It is used for the prophylaxis of graft rejection in organ and tissue transplantation. (From Martindale, The Extra Pharmacopoeia, 30th ed).		2.0110
acyclovir
Acyclovir: A GUANOSINE analog that acts as an antimetabolite. Viruses are especially susceptible. Used especially against herpes.. acyclovir : An oxopurine that is guanine substituted by a (2-hydroxyethoxy)methyl substituent at position 9. Used in the treatment of viral infections.		3.5202-aminopurines;
oxopurine		antimetabolite;
antiviral drug
rifampin
Rifampin: A semisynthetic antibiotic produced from Streptomyces mediterranei. It has a broad antibacterial spectrum, including activity against several forms of Mycobacterium. In susceptible organisms it inhibits DNA-dependent RNA polymerase activity by forming a stable complex with the enzyme. It thus suppresses the initiation of RNA synthesis. Rifampin is bactericidal, and acts on both intracellular and extracellular organisms. (From Gilman et al., Goodman and Gilman's The Pharmacological Basis of Therapeutics, 9th ed, p1160)		2.0310cyclic ketal;
hydrazone;
N-iminopiperazine;
N-methylpiperazine;
rifamycins;
semisynthetic derivative;
zwitterion		angiogenesis inhibitor;
antiamoebic agent;
antineoplastic agent;
antitubercular agent;
DNA synthesis inhibitor;
EC 2.7.7.6 (RNA polymerase) inhibitor;
Escherichia coli metabolite;
geroprotector;
leprostatic drug;
neuroprotective agent;
pregnane X receptor agonist;
protein synthesis inhibitor
clozapine
Clozapine: A tricylic dibenzodiazepine, classified as an atypical antipsychotic agent. It binds several types of central nervous system receptors, and displays a unique pharmacological profile. Clozapine is a serotonin antagonist, with strong binding to 5-HT 2A/2C receptor subtype. It also displays strong affinity to several dopaminergic receptors, but shows only weak antagonism at the dopamine D2 receptor, a receptor commonly thought to modulate neuroleptic activity. Agranulocytosis is a major adverse effect associated with administration of this agent.. clozapine : A benzodiazepine that is 5H-dibenzo[b,e][1,4]diazepine substituted by a chloro group at position 8 and a 4-methylpiperazin-1-yl group at position 11. It is a second generation antipsychotic used in the treatment of psychiatric disorders like schizophrenia.		2.0310benzodiazepine;
N-arylpiperazine;
N-methylpiperazine;
organochlorine compound		adrenergic antagonist;
dopaminergic antagonist;
EC 3.4.21.26 (prolyl oligopeptidase) inhibitor;
environmental contaminant;
GABA antagonist;
histamine antagonist;
muscarinic antagonist;
second generation antipsychotic;
serotonergic antagonist;
xenobiotic
sildenafil
sildenafil : A pyrazolo[4,3-d]pyrimidin-7-one having a methyl substituent at the 1-position, a propyl substituent at the 3-position and a 2-ethoxy-5-[(4-methylpiperazin-1-yl)sulfonyl]phenyl group at the 5-position.		2.0310piperazines;
pyrazolopyrimidine;
sulfonamide		EC 3.1.4.35 (3',5'-cyclic-GMP phosphodiesterase) inhibitor;
vasodilator agent
vardenafil
vardenafil : The sulfonamide resulting from formal condensation of the sulfo group of 4-ethoxy-3-(5-methyl-7-propylimidazo[5,1-f][1,2,4]triazin-4(1H)-one-2-yl)benzenesulfonic acid and the secondary amino group of 4-ethylpiperazine.		2.0310imidazotriazine;
N-alkylpiperazine;
N-sulfonylpiperazine		EC 3.1.4.* (phosphoric diester hydrolase) inhibitor;
vasodilator agent
aprepitant
Aprepitant: A morpholine neurokinin-1 (NK1) receptor antagonist that is used in the management of nausea and vomiting caused by DRUG THERAPY, and for the prevention of POSTOPERATIVE NAUSEA AND VOMITING.. aprepitant : A morpholine-based antiemetic, which is or the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. Aprepitant is a selective high-affinity antagonist of human substance P/neurokinin 1 (NK1) receptors.		2.0310(trifluoromethyl)benzenes;
cyclic acetal;
morpholines;
triazoles		antidepressant;
antiemetic;
neurokinin-1 receptor antagonist;
peripheral nervous system drug;
substance P receptor antagonist
ConditionIndicatedRelationship StrengthStudiesTrials
Granulomas
[description not available]		01.9610
Granuloma
A relatively small nodular inflammatory lesion containing grouped mononuclear phagocytes, caused by infectious and noninfectious agents.		01.9610
Innate Inflammatory Response
[description not available]		04.5451
Inflammation
A pathological process characterized by injury or destruction of tissues caused by a variety of cytologic and chemical reactions. It is usually manifested by typical signs of pain, heat, redness, swelling, and loss of function.		09.5451
B16 Melanoma
[description not available]		08.77100
Angiogenesis, Pathologic
[description not available]		03.5380
Herpes Simplex Keratitis
[description not available]		06.1641
Eye Infections, Viral
Infections of the eye caused by minute intracellular agents. These infections may lead to severe inflammation in various parts of the eye - conjunctiva, iris, eyelids, etc. Several viruses have been identified as the causative agents. Among these are Herpesvirus, Adenovirus, Poxvirus, and Myxovirus.		03.8521
Keratitis, Herpetic
A superficial, epithelial Herpesvirus hominis infection of the cornea, characterized by the presence of small vesicles which may break down and coalesce to form dendritic ulcers (KERATITIS, DENDRITIC). (Dictionary of Visual Science, 3d ed)		18.1641
Orphan Diseases
Rare diseases that have not been well studied.		02.1510
Arthritis, Post-Infectious
[description not available]		02.1510
Keratitis
Inflammation of the cornea.		06.1162
Arthritis, Reactive
An aseptic, inflammatory arthritis developing secondary to a primary extra-articular infection, most typically of the GASTROINTESTINAL TRACT or UROGENITAL SYSTEM. The initiating trigger pathogens are usually SHIGELLA; SALMONELLA; YERSINIA; CAMPYLOBACTER; or CHLAMYDIA TRACHOMATIS. Reactive arthritis is strongly associated with HLA-B27 ANTIGEN.		02.1510
Cancer of Colon
[description not available]		02.9640
Colonic Neoplasms
Tumors or cancer of the COLON.		02.9640
Cardiometabolic Syndrome
A cluster of symptoms that are risk factors for CARDIOVASCULAR DISEASES and TYPE 2 DIABETES MELLITUS. The major components not only include metabolic dysfunctions of METABOLIC SYNDROME but also HYPERTENSION, and ABDOMINAL OBESITY.		02.1710
Alloxan Diabetes
[description not available]		02.1710
Disease Models, Animal
Naturally-occurring or experimentally-induced animal diseases with pathological processes analogous to human diseases.		03.5280
Hyperglycemia, Postprandial
Abnormally high BLOOD GLUCOSE level after a meal.		02.1710
Hyperglycemia
Abnormally high BLOOD GLUCOSE level.		02.1710
Metabolic Syndrome
A cluster of symptoms that are risk factors for CARDIOVASCULAR DISEASES and TYPE 2 DIABETES MELLITUS. The major components of metabolic syndrome include ABDOMINAL OBESITY; atherogenic DYSLIPIDEMIA; HYPERTENSION; HYPERGLYCEMIA; INSULIN RESISTANCE; a proinflammatory state; and a prothrombotic (THROMBOSIS) state.		02.1710
Adjuvant Arthritis
[description not available]		03.360
Communicable Diseases, Emerging
Infectious diseases that are novel in their outbreak ranges (geographic and host) or transmission mode.		03.4711
Keratitis, Ulcerative
[description not available]		010.261411
Infections, Pseudomonas
[description not available]		06.9763
Bacterial Eye Infections
[description not available]		010.331511
Corneal Ulcer
Loss of epithelial tissue from the surface of the cornea due to progressive erosion and necrosis of the tissue; usually caused by bacterial, fungal, or viral infection.		010.261411
Pseudomonas Infections
Infections with bacteria of the genus PSEUDOMONAS.		06.9763
Age-Related Osteoporosis
[description not available]		02.110
Osteoporosis
Reduction of bone mass without alteration in the composition of bone, leading to fractures. Primary osteoporosis can be of two major types: postmenopausal osteoporosis (OSTEOPOROSIS, POSTMENOPAUSAL) and age-related or senile osteoporosis.		02.110
Diabetic Retinopathy
Disease of the RETINA as a complication of DIABETES MELLITUS. It is characterized by the progressive microvascular complications, such as ANEURYSM, interretinal EDEMA, and intraocular PATHOLOGIC NEOVASCULARIZATION.		02.420
Uveitis
Inflammation of part or all of the uvea, the middle (vascular) tunic of the eye, and commonly involving the other tunics (sclera and cornea, and the retina). (Dorland, 27th ed)		04.6232
Cerebral Nocardiosis
[description not available]		06.7833
Infectious Endophthalmitis
Infectious condition of the internal eye.		02.110
Endophthalmitis
Suppurative inflammation of the tissues of the internal structures of the eye frequently associated with an infection.		02.110
Atherogenesis
[description not available]		02.1110
Atherosclerosis
A thickening and loss of elasticity of the walls of ARTERIES that occurs with formation of ATHEROSCLEROTIC PLAQUES within the ARTERIAL INTIMA.		02.1110
Experimental Mammary Neoplasms
[description not available]		02.1310
Malignant Melanoma
[description not available]		02.1510
Melanoma
A malignant neoplasm derived from cells that are capable of forming melanin, which may occur in the skin of any part of the body, in the eye, or, rarely, in the mucous membranes of the genitalia, anus, oral cavity, or other sites. It occurs mostly in adults and may originate de novo or from a pigmented nevus or malignant lentigo. Melanomas frequently metastasize widely, and the regional lymph nodes, liver, lungs, and brain are likely to be involved. The incidence of malignant skin melanomas is rising rapidly in all parts of the world. (Stedman, 25th ed; from Rook et al., Textbook of Dermatology, 4th ed, p2445)		02.1510
Farsightedness
[description not available]		03.8121
Nearsightedness
[description not available]		03.4311
Hyperopia
A refractive error in which rays of light entering the eye parallel to the optic axis are brought to a focus behind the retina, as a result of the eyeball being too short from front to back. It is also called farsightedness because the near point is more distant than it is in emmetropia with an equal amplitude of accommodation. (Dorland, 27th ed)		03.8121
Myopia
A refractive error in which rays of light entering the EYE parallel to the optic axis are brought to a focus in front of the RETINA when accommodation (ACCOMMODATION, OCULAR) is relaxed. This results from an overly curved CORNEA or from the eyeball being too long from front to back. It is also called nearsightedness.		03.4311
Glaucoma, Suspect
[description not available]		03.3420
Fuch's Endothelial Dystrophy
[description not available]		02.0510
Fuchs' Endothelial Dystrophy
Disorder caused by loss of endothelium of the central cornea. It is characterized by hyaline endothelial outgrowths on Descemet's membrane, epithelial blisters, reduced vision, and pain.		02.0510
Glaucoma
An ocular disease, occurring in many forms, having as its primary characteristics an unstable or a sustained increase in the intraocular pressure which the eye cannot withstand without damage to its structure or impairment of its function. The consequences of the increased pressure may be manifested in a variety of symptoms, depending upon type and severity, such as excavation of the optic disk, hardness of the eyeball, corneal anesthesia, reduced visual acuity, seeing of colored halos around lights, disturbed dark adaptation, visual field defects, and headaches. (Dictionary of Visual Science, 4th ed)		02.3920
Intraocular Pressure
The pressure of the fluids in the eye.		04.6232
Keratoconus
A noninflammatory, usually bilateral protrusion of the cornea, the apex being displaced downward and nasally. It occurs most commonly in females at about puberty. The cause is unknown but hereditary factors may play a role. The -conus refers to the cone shape of the corneal protrusion. (From Dorland, 27th ed)		02.0510
Ocular Hypertension
A condition in which the intraocular pressure is elevated above normal and which may lead to glaucoma.		03.3420
Angioma
A vascular anomaly due to proliferation of blood or lymphatic vessels that forms a tumor-like mass. Vessels in the angioma may or may not be dilated.		02.0510
Hemangioma
A vascular anomaly due to proliferation of BLOOD VESSELS that forms a tumor-like mass. The common types involve CAPILLARIES and VEINS. It can occur anywhere in the body but is most frequently noticed in the SKIN and SUBCUTANEOUS TISSUE. (from Stedman, 27th ed, 2000)		02.0510
Benign Neoplasms
[description not available]		02.4720
Neoplasms
New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms.		02.4720
Bone Loss, Osteoclastic
[description not available]		02.0610
Plica Syndrome
[description not available]		02.0610
Synovitis
Inflammation of the SYNOVIAL MEMBRANE.		02.0610
Cicatrization
The formation of fibrous tissue in the place of normal tissue during the process of WOUND HEALING. It includes scar tissue formation occurring in healing internal organs as well as in the skin after surface injuries.		02.0810
Infections, Pneumococcal
[description not available]		05.0231
Day Blindness
[description not available]		02.0810
Cicatrix
The fibrous tissue that replaces normal tissue during the process of WOUND HEALING.		02.0810
Pneumococcal Infections
Infections with bacteria of the species STREPTOCOCCUS PNEUMONIAE.		05.0231
Eye Disorders
[description not available]		02.3420
Eye Diseases
Diseases affecting the eye.		02.3420
Necrotizing Pyelonephritis
[description not available]		01.9310
Pyelonephritis
Inflammation of the KIDNEY involving the renal parenchyma (the NEPHRONS); KIDNEY PELVIS; and KIDNEY CALICES. It is characterized by ABDOMINAL PAIN; FEVER; NAUSEA; VOMITING; and occasionally DIARRHEA.		06.9310
Necrosis
The death of cells in an organ or tissue due to disease, injury or failure of the blood supply.		02.0210
Rheumatoid Arthritis
[description not available]		07.0310
Arthritis, Rheumatoid
A chronic systemic disease, primarily of the joints, marked by inflammatory changes in the synovial membranes and articular structures, widespread fibrinoid degeneration of the collagen fibers in mesenchymal tissues, and by atrophy and rarefaction of bony structures. Etiology is unknown, but autoimmune mechanisms have been implicated.		02.0310
Bright Disease
A historical classification which is no longer used. It described acute glomerulonephritis, acute nephritic syndrome, or acute nephritis. Named for Richard Bright.		02.0310
Glomerulonephritis
Inflammation of the renal glomeruli (KIDNEY GLOMERULUS) that can be classified by the type of glomerular injuries including antibody deposition, complement activation, cellular proliferation, and glomerulosclerosis. These structural and functional abnormalities usually lead to HEMATURIA; PROTEINURIA; HYPERTENSION; and RENAL INSUFFICIENCY.		02.0310
Syndrome, VKH (Vogt Koyanagi Harada)
[description not available]		01.9310
Uveomeningoencephalitic Syndrome
A syndrome characterized by bilateral granulomatous UVEITIS with IRITIS and secondary GLAUCOMA, premature ALOPECIA, symmetrical VITILIGO, poliosis circumscripta (a strand of depigmented hair), HEARING DISORDERS, and meningeal signs (neck stiffness and headache). Examination of the cerebrospinal fluid reveals a pattern consistent with MENINGITIS, ASEPTIC. (Adams et al., Principles of Neurology, 6th ed, p748; Surv Ophthalmol 1995 Jan;39(4):265-292)		01.9310
Cancer of Skin
[description not available]		02.0410
Skin Neoplasms
Tumors or cancer of the SKIN.		02.0410
Calcification, Pathologic
[description not available]		02.6930
Corneal Diseases
Diseases of the cornea.		03.0950
Calcinosis
Pathologic deposition of calcium salts in tissues.		02.6930
Complication, Postoperative
[description not available]		03.7721
Postoperative Complications
Pathologic processes that affect patients after a surgical procedure. They may or may not be related to the disease for which the surgery was done, and they may or may not be direct results of the surgery.		03.7721
Acute Lymphoid Leukemia
[description not available]		01.9910
Precursor Cell Lymphoblastic Leukemia-Lymphoma
A neoplasm characterized by abnormalities of the lymphoid cell precursors leading to excessive lymphoblasts in the marrow and other organs. It is the most common cancer in children and accounts for the vast majority of all childhood leukemias.		01.9910
Colitis Gravis
[description not available]		0665
Colitis, Ulcerative
Inflammation of the COLON that is predominantly confined to the MUCOSA. Its major symptoms include DIARRHEA, rectal BLEEDING, the passage of MUCUS, and ABDOMINAL PAIN.		0665
Concomitant Strabismus
[description not available]		03.3811
Strabismus
Misalignment of the visual axes of the eyes. In comitant strabismus the degree of ocular misalignment does not vary with the direction of gaze. In noncomitant strabismus the degree of misalignment varies depending on direction of gaze or which eye is fixating on the target. (Miller, Walsh & Hoyt's Clinical Neuro-Ophthalmology, 4th ed, p641)		03.3811
Infections, Staphylococcal
[description not available]		0210
Infection, Postoperative Wound
[description not available]		0210
Abscess
Accumulation of purulent material in tissues, organs, or circumscribed spaces, usually associated with signs of infection.		0210
Staphylococcal Infections
Infections with bacteria of the genus STAPHYLOCOCCUS.		0210
Recrudescence
[description not available]		03.320
Iritis
Inflammation of the iris characterized by circumcorneal injection, aqueous flare, keratotic precipitates, and constricted and sluggish pupil along with discoloration of the iris.		02.9110
Keratitis, Acanthamoeba
[description not available]		0210
Human Adenovirus Infections
[description not available]		0210
Adenovirus Infections, Human
Respiratory and conjunctival infections caused by 33 identified serotypes of human adenoviruses.		0210
Keratoconjunctivitis
Simultaneous inflammation of the cornea and conjunctiva.		0210
Acanthamoeba Keratitis
Infection of the cornea by an ameboid protozoan which may cause corneal ulceration leading to blindness.		0210
Cataract, Membranous
[description not available]		02.9210
Allergic Conjunctivitis
[description not available]		02.9210
Eczema, Atopic
[description not available]		02.9210
Cataract
Partial or complete opacity on or in the lens or capsule of one or both eyes, impairing vision or causing blindness. The many kinds of cataract are classified by their morphology (size, shape, location) or etiology (cause and time of occurrence). (Dorland, 27th ed)		02.9210
Conjunctivitis, Allergic
Conjunctivitis due to hypersensitivity to various allergens.		02.9210
Dermatitis, Atopic
A chronic inflammatory genetically determined disease of the skin marked by increased ability to form reagin (IgE), with increased susceptibility to allergic rhinitis and asthma, and hereditary disposition to a lowered threshold for pruritus. It is manifested by lichenification, excoriation, and crusting, mainly on the flexural surfaces of the elbow and knee. In infants it is known as infantile eczema.		02.9210
Corneal Edema
An excessive amount of fluid in the cornea due to damage of the epithelium or endothelium causing decreased visual acuity.		02.9210
Atypical Mycobacterial Infection, Disseminated
[description not available]		0210
Berger Disease
[description not available]		0210
Glomerulonephritis, IGA
A chronic form of glomerulonephritis characterized by deposits of predominantly IMMUNOGLOBULIN A in the mesangial area (GLOMERULAR MESANGIUM). Deposits of COMPLEMENT C3 and IMMUNOGLOBULIN G are also often found. Clinical features may progress from asymptomatic HEMATURIA to END-STAGE KIDNEY DISEASE.		0210
Proteinuria
The presence of proteins in the urine, an indicator of KIDNEY DISEASES.		0210
Burns, Chemical
Burns caused by contact with or exposure to CAUSTICS or strong ACIDS.		01.9710
Eye Burns
Injury to any part of the eye by extreme heat, chemical agents, or ultraviolet radiation.		01.9710
Pink Eye
[description not available]		03.3611
Acute Myelogenous Leukemia
[description not available]		03.3611
Conjunctivitis
INFLAMMATION of the CONJUNCTIVA.		03.3611
Leukemia, Myeloid, Acute
Clonal expansion of myeloid blasts in bone marrow, blood, and other tissue. Myeloid leukemias develop from changes in cells that normally produce NEUTROPHILS; BASOPHILS; EOSINOPHILS; and MONOCYTES.		03.3611
Anesthesia
A state characterized by loss of feeling or sensation. This depression of nerve function is usually the result of pharmacologic action and is induced to allow performance of surgery or other painful procedures.		01.9710
Cornea Injuries
[description not available]		01.9610
Corneal Injuries
Damage or trauma inflicted to the CORNEA by external means.		01.9610
Proctitis
INFLAMMATION of the MUCOUS MEMBRANE of the RECTUM, the distal end of the large intestine (INTESTINE, LARGE).		04.3222
Ulcer
A lesion on the surface of the skin or a mucous surface, produced by the sloughing of inflammatory necrotic tissue.		03.3511
Dermatoses
[description not available]		01.9610
Skin Diseases
Diseases involving the DERMIS or EPIDERMIS.		01.9610
Colitis, Granulomatous
[description not available]		01.9610
Crohn Disease
A chronic transmural inflammation that may involve any part of the DIGESTIVE TRACT from MOUTH to ANUS, mostly found in the ILEUM, the CECUM, and the COLON. In Crohn disease, the inflammation, extending through the intestinal wall from the MUCOSA to the serosa, is characteristically asymmetric and segmental. Epithelioid GRANULOMAS may be seen in some patients.		01.9610
Aura
[description not available]		01.9610
Epilepsy
A disorder characterized by recurrent episodes of paroxysmal brain dysfunction due to a sudden, disorderly, and excessive neuronal discharge. Epilepsy classification systems are generally based upon: (1) clinical features of the seizure episodes (e.g., motor seizure), (2) etiology (e.g., post-traumatic), (3) anatomic site of seizure origin (e.g., frontal lobe seizure), (4) tendency to spread to other structures in the brain, and (5) temporal patterns (e.g., nocturnal epilepsy). (From Adams et al., Principles of Neurology, 6th ed, p313)		01.9610
Asthma, Bronchial
[description not available]		01.9610
Asthma
A form of bronchial disorder with three distinct components: airway hyper-responsiveness (RESPIRATORY HYPERSENSITIVITY), airway INFLAMMATION, and intermittent AIRWAY OBSTRUCTION. It is characterized by spasmodic contraction of airway smooth muscle, WHEEZING, and dyspnea (DYSPNEA, PAROXYSMAL).		01.9610